KINAMED PROFIX SYSTEM
FDA 510(k) clearance K964362 · decided 1997-01-16
Clearance details
- K-number
- K964362
- Device name
- KINAMED PROFIX SYSTEM
- Applicant
- Kinamed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-01
- Decision date
- 1997-01-16
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Newbury Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.