CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM
FDA 510(k) clearance K051293 · decided 2005-06-14
Clearance details
- K-number
- K051293
- Device name
- CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM
- Applicant
- Ceremed , Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-18
- Decision date
- 2005-06-14
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.