510(k) K901480
- Device
- F-20 TOTAL HIP PROSTHESIS
- Applicant
- MED-TEK CORP.
- 510(k) number
- K901480
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-12
- Date received
- 1990-03-27
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH EPLING
- Address
- 6535 E. 82nd St. Suite 215 Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3008556682
- 3007200272
- 9610612
- 3018094310
- 2648920
- 3008868758
- 1822565
- 1057425
- 8043792
- 3014302784
- 3010287737
- 3015259876
- 3021008900
- 3006356043
- 3014644608
- 1226544
- 3007366790
- 3008262872
- 3002806603
- 3006801265
- 1000547811
- 3019807891
- 3005180920
- 2244478
- 1644408
- 3013302242
- 2134285
- 3012392319
- 3000196378
- 3030412764
- 3010155648
- 3010065126
- 9613350
- 3006085220
- 3020155054
- 3008395353
- 3009871135
- 3033509898
- 3006017180
- 3009760038
- 3002807310
- 3010057495
- 3003998208
- 2246552
- 3003761012
- 3007740680
- 3009106092
- 3017397663
- 3043543260
- 1833986
- 3011295718
- 3009732568
- 2531477
- 3002806470
- 3036756245
- 3011015572
- 3005360851
- 1018470
- 3000931034
- 3003541440
- 8010379
- 3006395932
- 3010039400
- 3015207155
- 1219655
- 1828288
- 1038671
- 3010178296
- 1058584
- 1225675
- 3009888740
- 3005323511
- 3005751028
- 3004371426
- 3009756327
- 1645151
- 3009475821
- 9613369
- 3002807315
- 1722511
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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