AOS Small Bone Nailing System
FDA 510(k) clearance K163014 · decided 2017-01-24
Clearance details
- K-number
- K163014
- Device name
- AOS Small Bone Nailing System
- Applicant
- Advanced Orthopaedic Solutions, Inc. (Aos)
- Decision
- Substantially Equivalent
- Date received
- 2016-10-28
- Decision date
- 2017-01-24
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.