CANNULATED MALLEOLAR SCREW
FDA 510(k) clearance K931682 · decided 1994-04-05
Clearance details
- K-number
- K931682
- Device name
- CANNULATED MALLEOLAR SCREW
- Applicant
- Onyx Medical Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1993-04-05
- Decision date
- 1994-04-05
- Days to decision
- 365 days
- Clearance type
- Traditional
- Product code
- KWK
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.