IMMIX BONE GRAFT EXTENDER
FDA 510(k) clearance K013764 · decided 2002-05-16
Clearance details
- K-number
- K013764
- Device name
- IMMIX BONE GRAFT EXTENDER
- Applicant
- Osteogenics Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-13
- Decision date
- 2002-05-16
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- KKY
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.