OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
FDA 510(k) clearance K043421 · decided 2005-02-16
Clearance details
- K-number
- K043421
- Device name
- OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
- Applicant
- Regeneration Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-13
- Decision date
- 2005-02-16
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Alachua, FL, US
- Third-party review
- No
- Expedited review
- No
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