KSF SPINAL FIXATOR
FDA 510(k) clearance K931488 · decided 1994-01-21
Clearance details
- K-number
- K931488
- Device name
- KSF SPINAL FIXATOR
- Applicant
- Franklin Medical USA, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-03-25
- Decision date
- 1994-01-21
- Days to decision
- 302 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.