EXTERNAL FIXATOR
FDA 510(k) clearance K943857 · decided 1995-01-27
Clearance details
- K-number
- K943857
- Device name
- EXTERNAL FIXATOR
- Applicant
- Acu Med, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-08-08
- Decision date
- 1995-01-27
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- JEC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beaverton, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.