FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
FDA 510(k) clearance K041081 · decided 2004-07-01
Clearance details
- K-number
- K041081
- Device name
- FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
- Applicant
- Hand Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-26
- Decision date
- 2004-07-01
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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