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Devices
Device Recall SpheRx Posted Pedicle Screw System
Model / Serial
Batch: JK2043, JK2134, JK2364, JK2367
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Product Description
5.5mm x 45mm Noncannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
1 Event
Recall of Device Recall SpheRx Posted Pedicle Screw System
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Manufacturer
NuVasive Inc
Manufacturer Address
NuVasive Inc, 7475 Lusk Blvd, San Diego CA 92121-5707
Manufacturer Parent Company (2017)
NuVasive, Inc.
Source
USFDA
30 devices with a similar name
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Device Recall SpheRx Posted Pedicle Screw System
Model / Serial
Batch: JK2082, JK2095, JK2165
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Product Description
5.5mm x 50mm Cannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
Device Recall SpheRx Posted Pedicle Screw System
Model / Serial
Batch: JK2059, JK2084, JK2148
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Product Description
5.5mm x 55mm Cannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
Device Recall SpheRx Posted Pedicle Screw System
Model / Serial
Batch: JK2057, JK2157.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Product Description
6.5mm x 30mm Cannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
Device Recall SpheRx Posted Pedicle Screw System
Model / Serial
Batch: JK2083, JK2184
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Product Description
6.5mm x 35mm Cannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
Device Recall SpheRx Posted Pedicle Screw System
Model / Serial
Batch: JK2052, JK2070, JK2098, JK2160, JK2093, JK2159
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Product Description
6.5mm x 40mm Cannulated Screw Shank || Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
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