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Devices
Signature Patient Specific Surgical Guides
Model / Serial
42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in MI, ID, TX, and in France.
Product Description
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Manufacturer
Materialise N.V.
1 Event
Recall of Signature Patient Specific Surgical Guides
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Manufacturer
Materialise N.V.
Manufacturer Address
Materialise N.V., 15 Technologielaan, Heverlee Belgium
Manufacturer Parent Company (2017)
Materialise Nv
Source
USFDA
Language
English
Français
Español
한국어