Omnifit Uhmwpe Acetabular Shell Cement Space Syst.
FDA 510(k) K890649 · Osteonics Corp.
510(k) numberK890649
Submission
- Device name
- Omnifit Uhmwpe Acetabular Shell Cement Space Syst.
- Applicant
- Osteonics Corp.
Allendale, NJ, US - Received
- February 8, 1989
- Decision date
- March 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
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|---|---|---|
| K983657 | Osteonics Series 7000 Ad Tibial TrayHRY · Traditional | 04/06/2000SE |
| K980070 | Osteonics Ha-Coated DevicesMEH · Traditional | 07/23/1999SE |
| K984375 | Osteonics Spinal System - Sacral Offset Connector AssemblyKWP · Traditional | 04/30/1999SE |
| K982798 | Osteonics Anterior Cervical Compression Plating SystemKWQ · Traditional | 03/25/1999SE |
| K984585 | Osteonics +10 Unipolar Adaptor SleeveKWL · Traditional | 02/24/1999SE |
| K990203 | Osteonics Primary Secur-Fit Plus Hip StemsMEH · Special | 02/18/1999SE |
| K990158 | Osteonics Combination Screw Ring/BlockerMNI · Special | 02/01/1999SE |
| K984302 | Osteonics Spinal System Cylindrical Bone ScrewsMNH · Special | 12/18/1998SE |
| K984353 | Osteo 9MM Ic Tibial NailHSB · Special | 12/16/1998SE |
| K983502 | Osteonics Secur-Fit Ad Generation II Acetabular Component SystemLPH · Traditional | 12/16/1998SE |
Questions and answers
When was Omnifit Uhmwpe Acetabular Shell Cement Space Syst. cleared by the FDA?
Omnifit Uhmwpe Acetabular Shell Cement Space Syst. (K890649) received a 510(k) decision of Substantially Equivalent on March 13, 1989, 33 days after the submission was received.
What is the product code of K890649?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.