OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
FDA 510(k) clearance K121818 · decided 2013-02-07
Clearance details
- K-number
- K121818
- Device name
- OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
- Applicant
- Oxford Performance Materials
- Decision
- Substantially Equivalent
- Date received
- 2012-06-20
- Decision date
- 2013-02-07
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- GXN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- South Windsor, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.