510(k) K051407
- Device
- LEGEND ALL-POLY CUP
- Applicant
- ORTHO DEVELOPMENT CORP.
- 510(k) number
- K051407
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-09-08
- Date received
- 2005-05-31
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM J GRIFFIN
- Address
- 12187 S. Business Park Dr. Draper UT US 84020 84020
FDA Registration Numbers#
- 1834331
- 3005360851
- 3019807891
- 1221053
- 3003541440
- 1526534
- 3017397663
- 3004513872
- 3009760038
- 2242737
- 3016438694
- 1720929
- 2245304
- 3018094310
- 3002807315
- 3009546990
- 3010536692
- 3014763043
- 2528981
- 8010379
- 9614209
- 1828464
- 3008572101
- 3003998208
- 1722511
- 3010041993
- 3005581234
- 3011170410
- 3006395932
- 3000196378
- 3010363503
- 3005323511
- 3009732568
- 1000547811
- 9613350
- 1057425
- 3004371426
- 1822565
- 3004641308
- 3004153896
- 9681642
- 3006356043
- 3010041693
- 3008110533
- 3006801265
- 1833920
- 3013176080
- 3015516266
- 3011683674
- 3003595343
- 8044172
- 1835251
- 3010288357
- 3002806535
- 3015167917
- 1827096
- 3007366790
- 3012130008
- 3012319330
- 2249697
- 1721676
- 3009241418
- 1649518
- 3008556682
- 1424263
- 3010386387
- 3015398319
- 3007311878
- 3001278222
- 3020155054
- 3026771806
- 3004635447
- 1643264
- 9610612
- 9610726
- 8010916
- 9616680
- 3005061536
- 2134285
- 1818910
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JDI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020-12-11 |
Legacy Summary#
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FDA Review#
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