510(k) K032052
- Device
- UC-PLUS SOLUTION UNICONDYLAR KNEE
- Applicant
- Plus Orthopedics
- 510(k) number
- K032052
- Product code
- HRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-25
- Date received
- 2003-07-02
- Regulation
- 888.3530
- Classification name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- J.D. WEBB
- Address
- 1001 Oakwood Blvd. Round Rock TX US 78681 78681
FDA Registration Numbers#
- 1000550978
- 9616680
- 8010379
- 3007200272
- 3014315669
- 9610612
- 2244478
- 1423662
- 3021008900
- 3004986960
- 3033509898
- 1047843
- 3002907620
- 1421101
- 3009973505
- 3026771806
- 3011061242
- 3004371426
- 2249697
- 3008868758
- 1644408
- 3006395932
- 2245304
- 3017410889
- 3010097171
- 1064858
- 9616671
- 1057425
- 1818910
- 3009475821
- 1220477
- 3005061536
- 3010220595
- 3009888740
- 3010041693
- 3003998208
- 3008021110
- 3010047402
- 1020279
- 1061927
- 3003639920
- 1825034
- 3002806470
- 1226544
- 3007539489
- 3009241418
- 3008658204
- 1649518
- 3013055499
- 1822565
- 3016438694
- 3013791180
- 3010536692
- 3009555440
- 3009848551
- 1526534
- 3025603301
- 1219655
- 3009546990
- 3007311878
- 3015207155
- 3010173425
- 3011274144
- 3010288357
- 3004748528
- 3020703621
- 2134285
- 1828464
- 3009882462
- 2249615
- 3003477135
- 3003387384
- 3002807310
- 3006801265
- 1834331
- 1054811
- 3002808022
- 3011295718
- 3008744062
Source Documents#
Other 510(k) Records For Product Code HRY#
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|---|---|---|---|
| K193549 | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | 2020-04-16 |
| K190633 | NanoOrtho NanoKnee® System | Nanoortho, LLC | 2019-12-20 |
| K152631 | MPO Total Knee Systems MR Labeling | Microport Orthopedics, Inc. | 2016-03-23 |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corporation | 2015-03-20 |
| K133940 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | Biomet UK, Ltd. | 2014-03-28 |
| K131167 | UNIVATION | Aesculap Implant Systems, LLC | 2013-10-17 |
| K122277 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM | Biomet Manufacturing Corp | 2012-10-22 |
| K110415 | SIGNATURE PLANNER / SIGNATURE GUIDES | Materialise NV | 2011-05-16 |
| K100973 | EVOLUTION UNICONDYLAR KNEE SYSTEM | Wrightmedicaltechnologyinc | 2010-08-10 |
| K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | 2008-10-03 |
| K081293 | UNIVATION UNICONDYLAR KNEE SYSTEM | Aesculap Implant Systems, Inc. | 2008-09-22 |
| K072704 | UNICOMPARTMENTAL KNEE | Valpo Orthopedic Technology, Inc. | 2008-02-19 |
| K071881 | TRIATHLON PKR SYSTEM | Howmedica Osteonics Corp. | 2007-10-09 |
| K070267 | DEPUY GCK TIBIAL COMPONENTS | DePuy Orthopaedics, Inc. | 2007-08-17 |
| K063515 | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE | Biomet Manufacturing, Inc. | 2007-02-02 |