510(k) K030265 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 4, 2003 |
| Received | Jan 27, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030265
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 22 consists of all product under product code: JDI and same usage:
Item no:
811400218 CPT 12/14 COCR REVISION S
811400318 CPT 12/14 COCR REVISION S
811400420 CPT 12/14 COCR REVISION S
81140 Terminated |
JDI | None listed |
| Feb 22, 2016 | Zimmer Biomet, Inc. CPT 12/14 COCR
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
various sizes
The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disa Terminated |
JDI | None listed |
| Feb 20, 2014 | Zimmer, Inc. CPT 12/14 COCR (various sizes) Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.