CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
FDA 510(k) clearance K101235 · decided 2010-10-25
Clearance details
- K-number
- K101235
- Device name
- CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
- Applicant
- Neos Surgery S.L
- Decision
- Substantially Equivalent
- Date received
- 2010-05-03
- Decision date
- 2010-10-25
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GXR
- Device class
- 2
- Regulation number
- 882.5250
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alexandria, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.