510(k) K051335
- Device
- ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
- Applicant
- EXACTECH, INC.
- 510(k) number
- K051335
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-06-21
- Date received
- 2005-05-23
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARITZA ELIAS
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3020282716
- 3010057495
- 1649518
- 3015167917
- 3007913880
- 3017410889
- 1529009
- 3004371426
- 3008395353
- 3006809628
- 3009173317
- 3005718816
- 3012319330
- 3043543260
- 3010132111
- 3007200272
- 1018470
- 3002806603
- 3003541440
- 1833506
- 9614209
- 2246552
- 2245304
- 2011171
- 1834379
- 3030412764
- 3025603301
- 3010363503
- 2531477
- 3013450937
- 3009106092
- 3015398319
- 3011295718
- 3002806470
- 2528981
- 9681465
- 3013014058
- 1833986
- 3002807310
- 3010120135
- 3005751028
- 3005551626
- 3006128100
- 3022142628
- 3009959868
- 3010287737
- 3011274144
- 3003387384
- 3009760038
- 3007923096
- 3015207155
- 3009871135
- 3005360851
- 3020967480
- 1043653
- 3010536692
- 1721676
- 3007740680
- 8010916
- 1643264
- 3012725451
- 3005323511
- 3012130008
- 1020279
- 3005180920
- 3015978338
- 3014302784
- 3000931034
- 3015542154
- 3010065126
- 3004142400
- 9613350
- 1038671
- 3002807314
- 3009973505
- 3008868758
- 1649390
- 8010379
- 1000547811
- 3018094310
Source Documents#
Other 510(k) Records For Product Code JDI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026-08-24 |
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026-03-12 |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | 2025-07-31 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | 2024-10-21 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022-07-22 |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | 2021-12-10 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 |
| K203588 | ELEOS™ Limb Salvage System | Onkos Surgical | 2021-02-05 |
Legacy Summary#
summary
FDA Review#
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