510(k) K111572 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
| Applicant | Serf, Round Rock TX, US |
| Decision | Substantially Equivalent, Aug 29, 2011 |
| Received | Jun 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111572
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2020 | OMNIlife science Inc. SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures.
Product Code: H6-25128 Terminated |
LZO | None listed |
| Dec 21, 2020 | OMNIlife science Inc. SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures.
Product Code: H6-24728 Terminated |
LZO | None listed |
| Dec 21, 2020 | OMNIlife science Inc. SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures.
Product Code: H6-24928 Terminated |
LZO | None listed |
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
Serf Dual Mobility Cup Liner 53-28;
Product code: H6-25328 Terminated |
LZO | None listed |
| Jul 23, 2019 | OMNIlife science Inc. OMNIlife science, Inc.
ApeX acetabular liner
hip prosthesis component
Serf Dual Mobility Cup Insert Liner 51-28;
Product code: H6-25128 Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.