COBALT MV BONE CEMENT
FDA 510(k) clearance K091608 · decided 2009-09-17
Clearance details
- K-number
- K091608
- Device name
- COBALT MV BONE CEMENT
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2009-06-03
- Decision date
- 2009-09-17
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- LOD
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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| OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement (K211869) | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | 2022-05-19 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS recall (Z-0065-2018) | Encore Medical, Lp | 2017-11-06 |
| Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, M recall (Z-0066-2018) | Encore Medical, Lp | 2017-11-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110) | Biomet Manufacturing Corp | 2025-06-24 |
| Oxford® Partial Knee System (P010014/S107) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Cementless Partial Knee System (P010014/S105) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Partial Knee System (P010014/S108) | Biomet Manufacturing Corp | 2024-11-18 |
| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |