2.0 / 1.5mm Sp-1770
2.0 / 1.5mm Sp-1770 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K113512 on 29 Jun 2012 (1 earlier submission) and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036143688), 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 | Number00841036143688 | Date11 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113512 | Date29 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 00841036143688
- FDA 510(k) database K113512
- FDA 510(k) database K980512
Across registries
- FDA 510(k) K113512 decided 29 Jun 2012 Active
- FDA GUDID UDI-DI 00841036143688 listed 11 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K980512
- Cleared FDA 510(k) K113512
- Listed FDA GUDID 00841036143688
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 2.0 / 1.5mm
- Generic name
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Model / Ref / Catalog
- SP-1770
- Primary DI / UDI-DI
- 00841036143688
- FDA product code
- HWC, JEY
- GMDN term
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Device class
- Class II
- Regulation number
- 888.3040, 872.4760
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Craniofacial fixation plate, non-bioabsorbable, non-customized.