AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
FDA 510(k) clearance K052491 · decided 2005-10-07
Clearance details
- K-number
- K052491
- Device name
- AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
- Applicant
- Axya Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-12
- Decision date
- 2005-10-07
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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