The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Stories - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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Model / Serial
Lot Numbers: J49236, V07241, V30655, V47575 and V49404
- Product Classification
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Device Class
2
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Implanted device?
Yes
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Distribution
US Nationwide distribution in the states of CA, FL, MD and VT
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Product Description
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 || Product Usage: || Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
- Manufacturer
- 1 Event
Manufacturer
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Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
- Manufacturer Parent Company (2017)
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Source
USFDA
843 devices with a similar name
Learn more about the data here
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Model / Serial
Part Number 5190020775; Lot 9216017
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.
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Product Description
Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories. || These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
- Manufacturer
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Model / Serial
Verisions 1.0 and 1.1; all batches: GC400F3001; GC700F3001; GCN00F3002; GCU00F3002; GCV00F3002; H1800F3002; H1P00F3002; H1Q00F3002; H1V00F3002; H2600F3002; H2M00F3002; H2P00F3003; H3800F3003; H3D00F3003; H3G00F3003; H3T00F3003; H3U00F3003; H4C00F3003; H4Q00F3003; H5300F3003; H5800F3003; H6500F3003; H6600F3003; H6B00F3003; H6N00F3003; H7400F3003; H7R00F3003; H7X00F3003; H8700F3003; H9U00F3003; H9V00F3003; HA500F3003; HAH00F3003; HBF00F3003; HBL00F3003; HBN00F3003; HBU00F3003; HBW00F3003; HC300F3003; and HC600F3003.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
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Product Description
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. || It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
- Manufacturer
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Model / Serial
Verisions 1.0 and 1.1; all batches: H2200F3002; H3D00F3003; H7900F3003; H7P00F3003; H9U00F3003; and HC400F3003.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
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Product Description
Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-650-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
- Manufacturer
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Model / Serial
Verisions 1.0 and 1.1; all batches: HCE00F3002; HCL00F3002; J2J00F3002; J2L00F3002; J3500F3002; J3K00F3002; J3T00F3002; J4100F3002; J4900F3002; J5500F3002; J5600F3002; J6500F3002; J6C00F3002; J7A00F3002; J8100F3002; J8C00F3002; J8S00F3002; J9300F3002; J9900F3002; JA600F3002; JBJ00F3002; JBT00F3002; JC100F3002; JCK00F3002; JCV00F3002; JCW00F3002; K1700F3002; K3400F3002; K3G00F3003; K3K00F3003; K3X00F3003; K4H00F3003; K5800F3003; K5L00F3003; K6A00F3003; K6F00F3003; K6W00F3003; K7200F3003; K7600F3003; K7900F3003; K8700F3003; K8A00F3003; K8T00F3003; K9200F3003; K9E00F3003; K9P00F3003; K9W00F3003; KA100F3003; KAE00F3003; KAP00F3003; KAT00F3003; KB500F3003; KBT00F3003; KC400F3003; KCG00F3003; KCX00F3003; L1B00F3003; L1E00F3003; L1K00F3003; L2800F3003; L3100F3003; L3B00F3003; L3G00F3003; L3S00F3003; L4700F3003; L5A00F3003; L5J00F3003; L6N00F3003; L6U00F3003; L7500F3003; L7K00F3003; L8P00F3003; L9P00F3003; LA500F3003; LAB00F3003; and LAD00F3003.
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
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Product Description
Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
- Manufacturer
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Model / Serial
verisions 1.0 and 1.1; all batches: HCU00F3002; J1800F3002; J1B00F3002; J1H00F3002; J1R00F3002; J2400F3002; J2K00F3002; J2U00F3002; J4E00F3002; and K4100F3003
- Product Classification
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Device Class
2
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Implanted device?
No
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Distribution
Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
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Product Description
Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number 6000-651-100. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
- Manufacturer