Townley All Poly Acetabular Cup
FDA 510(k) K952731 · Biologically Oriented Prostheses
510(k) numberK952731
Submission
- Device name
- Townley All Poly Acetabular Cup
- Applicant
- Biologically Oriented Prostheses
Port Huron, MI, US - Received
- June 15, 1995
- Decision date
- December 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
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| K002325 | Wujin #3 Tibial NailJDS · Traditional | 10/30/2000SE |
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| K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentKYI · Traditional | 02/03/1997SE |
| K962769 | Horizon Hip SystemLPH · Traditional | 10/03/1996SE |
| K955916 | Townley Total Elbow SystemJDC · Traditional | 08/08/1996SE |
| K954768 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 01/18/1996SE |
| K953045 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 09/27/1995SN |
| K951356 | Various Uhmwp Hip & Knee Joint Prosthesis ModifiedLPH · Traditional | 06/19/1995SN |
Questions and answers
When was Townley All Poly Acetabular Cup cleared by the FDA?
Townley All Poly Acetabular Cup (K952731) received a 510(k) decision of Substantially Equivalent on December 28, 1995, 196 days after the submission was received.
What is the product code of K952731?
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.