CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
FDA 510(k) clearance K992905 · decided 2000-08-01
Clearance details
- K-number
- K992905
- Device name
- CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-08-30
- Decision date
- 2000-08-01
- Days to decision
- 337 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.