TRIMED OSTEOTOMY PLATE
FDA 510(k) clearance K043263 · decided 2005-01-14
Clearance details
- K-number
- K043263
- Device name
- TRIMED OSTEOTOMY PLATE
- Applicant
- TriMed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-24
- Decision date
- 2005-01-14
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Saugus, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.