SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
FDA 510(k) clearance K051600 · decided 2005-07-27
Clearance details
- K-number
- K051600
- Device name
- SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2005-06-16
- Decision date
- 2005-07-27
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjuncti recall (Z-1324-2009) | Synthes Spine | 2009-05-29 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |