FDA.reportPublic FDA data

Bone-resection orthopaedic reamer, reusable

Definition
An orthopaedic surgical instrument intended to resect bone (cut out part of the bone) and precisely shape a specific area of bone to accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); some types may in addition be designed to be used endoscopically to resect hypertrophic tissue [e.g., ligamentum flavum] to relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.
GUDID devices
312
Last updated
2023-09-28 07:19:44

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00885556911228TRIGENSmith & Nephew, Inc.E0018149-12023-09-20
00885556911235TRIGENSmith & Nephew, Inc.E0018149-22023-09-20
00885556911242TRIGENSmith & Nephew, Inc.E0018149-32023-09-20
00885556911259TRIGENSmith & Nephew, Inc.E0018149-42023-09-20
00885556911266TRIGENSmith & Nephew, Inc.E0018149-52023-09-20
00885556911273TRIGENSmith & Nephew, Inc.E0018149-62023-09-20
00885556911280TRIGENSmith & Nephew, Inc.E0018149-72023-09-20
00885556911297TRIGENSmith & Nephew, Inc.E0018149-82023-09-20
00885556911303TRIGENSmith & Nephew, Inc.E0018149-92023-09-20
00885556911310TRIGENSmith & Nephew, Inc.E0018149-102023-09-20
00885556911327TRIGENSmith & Nephew, Inc.E0018149-112023-09-20
00885556911334TRIGENSmith & Nephew, Inc.E0018149-122023-09-20
00885556911341TRIGENSmith & Nephew, Inc.E0018149-132023-09-20
00885556911358TRIGENSmith & Nephew, Inc.E0018149-142023-09-20
00885556911365TRIGENSmith & Nephew, Inc.E0018149-152023-09-20
00885556912669Trauma - ShouldersSmith & Nephew, Inc.E0018145-12023-09-20
00885556912676Trauma - ShouldersSmith & Nephew, Inc.E0018145-22023-09-20
00885556912683Trauma - ShouldersSmith & Nephew, Inc.E0018145-32023-09-20
00885556912690Trauma - ShouldersSmith & Nephew, Inc.E0018145-42023-09-20
00190446823094DJO SURGICALEncore Medical, L.P.S-2016702023-09-19
00885556911068PolarSmith & Nephew, Inc.E0018137-12023-09-15
00885556911075PolarSmith & Nephew, Inc.E0018137-22023-09-15
08800108696936LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.PT01-01062023-09-08
08800108696950LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.PT01-02072023-09-08
08800108696967LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.PT01-02082023-09-09
08800108696974LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.PT01-02092023-09-08
08800108696981LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.PT01-02102023-09-08
08800108667745LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LC01-03112023-09-07
08800108667769LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LC01-03122023-09-07
08800108667783LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LC01-03132023-09-07
08800108667806LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LC01-03142023-09-07
00816127024344iNSitu™ Hip SystemNEXTSTEP ARTHROPEDIX, LLC10-95-31132023-09-06
00841690189121APEX Knee SystemOmni Life Science, Inc.KS-991112023-01-10
00841690191759APEX Knee SystemOmni Life Science, Inc.KR-562602023-01-10
00841690191766APEX Knee SystemOmni Life Science, Inc.KR-562502023-01-10
05055662968279Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734011-NS2023-01-31
05055662968286Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734012-NS2023-01-31
05055662968293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734013-NS2023-01-31
05055662968309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734014-NS2023-01-31
05055662968316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734021-NS2023-01-31
05055662968323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734022-NS2023-01-31
05055662968330Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734023-NS2023-01-31
05055662968347Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS734024-NS2023-01-31
10603295549673INHANCEDEPUY (IRELAND)6507-00-1022022-12-09
00811801031465KodiakALPHATEC SPINE, INC.CI-102732020-09-19
00816127023422iNSitu™ Hip SystemNEXTSTEP ARTHROPEDIX, LLC10-95-20042023-09-05
00816127023439iNSitu™ Hip SystemNEXTSTEP ARTHROPEDIX, LLC10-95-20052023-09-05
00841690110644APEX Knee SystemOmni Life Science, Inc.WS-400292023-01-10
00841690110651APEX Knee SystemOmni Life Science, Inc.WS-400322023-01-10
00841690110668APEX Knee SystemOmni Life Science, Inc.WS-400352023-01-10
00841690110675APEX Knee SystemOmni Life Science, Inc.WS-400382023-01-10
00841690110682APEX Knee SystemOmni Life Science, Inc.WS-400652023-01-10
00841690110705APEX Knee SystemOmni Life Science, Inc.WS-400502023-01-10
00841690116929APEX Knee SystemOmni Life Science, Inc.KS-660012023-01-10
00841690116936APEX Knee SystemOmni Life Science, Inc.KS-660022023-01-10
00841690116943APEX Knee SystemOmni Life Science, Inc.KS-660032023-01-10
00841690116950APEX Knee SystemOmni Life Science, Inc.KS-660112023-01-10
00841690117308APEX Knee SystemOmni Life Science, Inc.KR-500852023-01-10
00841690117469APEX Knee SystemOmni Life Science, Inc.KR-500952023-01-10
00841690117476APEX Knee SystemOmni Life Science, Inc.KR-501052023-01-10
00841690117483APEX Knee SystemOmni Life Science, Inc.KR-501152023-01-10
00841690117490APEX Knee SystemOmni Life Science, Inc.KR-501252023-01-10
00841690117506APEX Knee SystemOmni Life Science, Inc.KR-501352023-01-10
00841690117513APEX Knee SystemOmni Life Science, Inc.KR-501452023-01-10
00841690117520APEX Knee SystemOmni Life Science, Inc.KR-501552023-01-10
00841690117537APEX Knee SystemOmni Life Science, Inc.KR-501652023-01-10
00841690117544APEX Knee SystemOmni Life Science, Inc.KR-501752023-01-10
00841690117551APEX Knee SystemOmni Life Science, Inc.KR-501852023-01-10
00841690117643APEX Knee SystemOmni Life Science, Inc.KR-500052023-01-10
00841690122036APEX Knee SystemOmni Life Science, Inc.KS-670622023-01-10
00841690122500APEX Knee SystemOmni Life Science, Inc.KS-670402023-01-10
00841690125518APEX Knee SystemOmni Life Science, Inc.KR-501952023-01-10
00841690127406APEX Knee SystemOmni Life Science, Inc.XK-000082023-01-10
00841690127413APEX Knee SystemOmni Life Science, Inc.WS-400512023-01-10
00841690127550APEX Knee SystemOmni Life Science, Inc.KS-992232023-01-10
00841690127581APEX Knee SystemOmni Life Science, Inc.KS-991342023-01-10
00841690127598APEX Knee SystemOmni Life Science, Inc.KS-991232023-01-10
00841690127833APEX Knee SystemOmni Life Science, Inc.KR-542602023-01-10
00841690127840APEX Knee SystemOmni Life Science, Inc.KR-502652023-01-10
00841690127857APEX Knee SystemOmni Life Science, Inc.KR-50185-R2023-01-10