AXYALOOP NONABSORBABLE BONE ANCHOR
FDA 510(k) clearance K060970 · decided 2006-07-05
Clearance details
- K-number
- K060970
- Device name
- AXYALOOP NONABSORBABLE BONE ANCHOR
- Applicant
- Axya Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-07
- Decision date
- 2006-07-05
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JDR
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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