CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
FDA 510(k) clearance K946165 · decided 1995-05-23
Clearance details
- K-number
- K946165
- Device name
- CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM
- Applicant
- Elekta Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-12-19
- Decision date
- 1995-05-23
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.