510(k) K051496 ยท LOD Bone Cement
COBALT BONE CEMENT
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 4, 2005 |
| Received | Jun 6, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2017 | Encore Medical, Lp Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS
Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee Open, Classified |
LOD | None listed |
| Nov 6, 2017 | Encore Medical, Lp Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS
Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic pro Open, Classified |
LOD | None listed |
| Apr 25, 2017 | Zimmer Biomet, Inc. Cobalt HV Bone Cement
Cobalt MV Bone Cement
Cobalt HV Bone Cement With Gentamicin Terminated |
LOD | None listed |
| Aug 19, 2016 | Encore Medical, Lp Cobalt HV Bone Cement
Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement. Terminated |
LOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.