CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
FDA 510(k) clearance K040864 · decided 2004-06-17
Clearance details
- K-number
- K040864
- Device name
- CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
- Applicant
- Aesculap
- Decision
- Substantially Equivalent
- Date received
- 2004-04-02
- Decision date
- 2004-06-17
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- GXN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.