ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
FDA 510(k) clearance K130147 · decided 2013-05-03
Clearance details
- K-number
- K130147
- Device name
- ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
- Applicant
- Small Bone Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-22
- Decision date
- 2013-05-03
- Days to decision
- 101 days
- Clearance type
- Special
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Morrisville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.