RESORBABLE CRANIAL CLAMPS
FDA 510(k) clearance K021408 · decided 2002-07-29
Clearance details
- K-number
- K021408
- Device name
- RESORBABLE CRANIAL CLAMPS
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 2002-05-03
- Decision date
- 2002-07-29
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GXR
- Device class
- 2
- Regulation number
- 882.5250
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Paoli, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |