TRAUMA INTERNAL FIXATION SYSTEMS
FDA 510(k) clearance K111663 · decided 2012-03-12
Clearance details
- K-number
- K111663
- Device name
- TRAUMA INTERNAL FIXATION SYSTEMS
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-14
- Decision date
- 2012-03-12
- Days to decision
- 272 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
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 |