ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
FDA 510(k) clearance K061451 · decided 2006-08-11
Clearance details
- K-number
- K061451
- Device name
- ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
- Applicant
- Ascension Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-25
- Decision date
- 2006-08-11
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KYI
- Device class
- 2
- Regulation number
- 888.3770
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of t recall (Z-1568-2013) | Integra LifeSciences Corp. | 2013-06-21 |