FDA.reportPublic FDA data

Bone screw fixation sleeve

Definition
An implantable tube-like sleeve intended to provide a secure fixing for a bone screw (e.g. orthopaedic, spinal) which has lost purchase due to screw loosening, back out, or breakage. It is inserted into the screw hole so that when a screw is inserted, a mechanical wedge is created as it is tightened. The sleeve is made of a non-bioabsorbable polymer and sleeve size is adjusted/configured intraoperatively. Disposable devices associated with implantation may be supplied with the sleeve.
GUDID devices
29
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840124516762FibFixFUSION ORTHOPEDICS, LLCTN-FN-80002026-04-09
00840124517776FibFixFUSION ORTHOPEDICS, LLCTN-FN-8000-S2026-04-09
00810050690027Ogmend®WOVEN ORTHOPEDIC TECHNOLOGIES LLC50-10032025-07-21
00810050690041Ogmend®WOVEN ORTHOPEDIC TECHNOLOGIES LLC32-6500M2025-07-21
00810050690058Ogmend®WOVEN ORTHOPEDIC TECHNOLOGIES LLC32-8500L2025-07-21
00840124518452FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCTN-CS-80092025-05-16
00840124518469FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCTN-CS-80142025-05-16
00840124518476FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCTN-CS-80162025-05-16
00840124518483FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCTN-CS-80252025-05-16
00840124518490FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCTN-CS-80302025-05-16
00840124518506FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCTN-CS-80352025-05-16
00840124518513FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCTN-CS-80402025-05-16
00840124519992PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-70502025-05-16
00840124520004PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-70512025-05-16
00840124520011PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-70522025-05-16
00840124520158PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-50272025-05-16
00840124520165PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-50352025-05-16
00840124520172PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-50402025-05-16
00840124520219PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-50752025-05-16
00840124519596PolyLockFUSION ORTHOPEDICS, LLCTN-SB-50242025-05-15
00840124519626PolyLockFUSION ORTHOPEDICS, LLCTN-SB-50272025-05-15
00840124519725PolyLockFUSION ORTHOPEDICS, LLCTN-SB-70032025-05-15
00840124519756PolyLockFUSION ORTHOPEDICS, LLCTN-TB-70032025-05-15
00840124519770PolyLockFUSION ORTHOPEDICS, LLCTN-TB-70042025-05-15
00840124519015FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-FT-91252025-05-14
00840124519022FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-FT-91352025-05-14
00840124519039FuzeFix Max FTFUSION ORTHOPEDICS, LLCTN-FT-91452025-05-14
00840124519213IntraLockFUSION ORTHOPEDICS, LLCTN-LL-58602025-05-14
10886982347572NASynthes GmbH08.233.001S2024-12-03