FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
FDA 510(k) clearance K091812 · decided 2010-05-07
Clearance details
- K-number
- K091812
- Device name
- FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
- Applicant
- Frontier Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-18
- Decision date
- 2010-05-07
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Pelham, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.