Metagen All Poly Acetabular Cup System
FDA 510(k) K964003 · Metagen, LLC
510(k) numberK964003
Submission
- Device name
- Metagen All Poly Acetabular Cup System
- Applicant
- Metagen, LLC
Menomonie, WI, US - Received
- October 7, 1996
- Decision date
- March 21, 1997
- 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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| 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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|---|---|---|
| K983976 | Metagen Activelock Wire Cerclage SystemJDQ · Traditional | 12/30/1998SE |
| K980609 | Segmental Defect Replacement SystemHSB · Traditional | 05/18/1998SE |
| K980020 | Activelock Modular Femoral Hip SystemLPH · Traditional | 04/03/1998SN |
| K963700 | Metagen High Tibial Osteotomy SystemHRS · Traditional | 02/12/1997SE |
Questions and answers
When was Metagen All Poly Acetabular Cup System cleared by the FDA?
Metagen All Poly Acetabular Cup System (K964003) received a 510(k) decision of Substantially Equivalent on March 21, 1997, 165 days after the submission was received.
What is the product code of K964003?
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.