MAYFIELD INFINITY SKULL CLAMP
FDA 510(k) clearance K051440 · decided 2005-09-20
Clearance details
- K-number
- K051440
- Device name
- MAYFIELD INFINITY SKULL CLAMP
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-02
- Decision date
- 2005-09-20
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- HBL
- Device class
- 2
- Regulation number
- 882.4460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.