Mayfield® 439A1021
Mayfield® 439A1021 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K130389 on 23 Apr 2013 (1 earlier submission) and listed in FDA GUDID since 25 Jul 2016 (UDI-DI 10381780256052), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10381780256052 | Date25 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130389 | Date23 Apr 2013 | StatusActive |
Official records
- AccessGUDID record 10381780256052
- FDA 510(k) database K130389
- FDA 510(k) database K090506
Across registries
- FDA 510(k) K130389 decided 23 Apr 2013 Active
- FDA GUDID UDI-DI 10381780256052 listed 25 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K090506
- Cleared FDA 510(k) K130389
- Listed FDA GUDID 10381780256052
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mayfield®
- Generic name
- Skull clamp
- Model / reference
- 439A1021
- Primary DI / UDI-DI
- 10381780256052
- FDA product code
- HBL
- GMDN term
- Skull clamp
- Device class
- Class II
- Regulation number
- 882.4460
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Skull clamp.