510(k) K091608 ยท LOD Bone Cement
COBALT MV BONE CEMENT
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 17, 2009 |
| Received | Jun 3, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091608
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2017 | Encore Medical, Lp Cobalt MV Bone Cement 40GM, REF 402438, 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 MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.