3.Omm Biomet Cannulated Screw System
FDA 510(k) clearance K143188 · decided 2014-12-30
Clearance details
- K-number
- K143188
- Device name
- 3.Omm Biomet Cannulated Screw System
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2014-11-05
- Decision date
- 2014-12-30
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item recall (Z-0616-2021) | Biomet, Inc. | 2020-12-17 |
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 |