DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
FDA 510(k) clearance K071417 · decided 2007-08-02
Clearance details
- K-number
- K071417
- Device name
- DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-21
- Decision date
- 2007-08-02
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- MBH
- Device class
- 2
- Regulation number
- 888.3565
- 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 |
|---|---|---|
| LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0828-2013) | DePuy Orthopaedics, Inc. | 2013-02-15 |
| LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0829-2013) | DePuy Orthopaedics, Inc. | 2013-02-15 |
| LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0830-2013) | DePuy Orthopaedics, Inc. | 2013-02-15 |
| LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS Sys recall (Z-0831-2013) | DePuy Orthopaedics, Inc. | 2013-02-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CERAMAX® Ceramic Total Hip System (P070026/S128) | DePuy Orthopaedics, Inc. | 2026-07-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S127) | DePuy Orthopaedics, Inc. | 2026-06-03 |
| Ceramax® Ceramic Hip System (P070026/S125) | DePuy Orthopaedics, Inc. | 2026-04-29 |
| Ceramax Ceramic Hip System (P070026/S124) | DePuy Orthopaedics, Inc. | 2026-04-10 |
| Ceramax® Ceramic Total Hip System (P070026/S118) | DePuy Orthopaedics, Inc. | 2026-01-08 |
| 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 |