ANATOMIC LOCKING PLATING SYSTEM
FDA 510(k) clearance K082300 · decided 2009-02-18
Clearance details
- K-number
- K082300
- Device name
- ANATOMIC LOCKING PLATING SYSTEM
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-12
- Decision date
- 2009-02-18
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- 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 |
|---|---|---|
| A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of recall (Z-0450-2016) | Biomet, Inc. | 2015-12-18 |
| Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 recall (Z-0716-2014) | Biomet, Inc. | 2014-01-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |