Bite Compression Screws 1
by Orthofix, Inc. 628 variants
Bite Compression Screws 1 (001-A-20001) is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K132893 on 20 Nov 2013 and listed in FDA GUDID since 21 Jun 2017 (UDI-DI 18056099646772), 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 | Number18056099646772 | Date21 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132893 | Date20 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 18056099646772
- FDA 510(k) database K132893
Across registries
- FDA 510(k) K132893 decided 20 Nov 2013 Active
- FDA GUDID UDI-DI 18056099646772 listed 21 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K132893
- Listed FDA GUDID 18056099646772
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bite Compression Screws
- Generic name
- Fluted surgical drill bit, single-use
- Model / Ref / Catalog
- 1, 001-A-20001
- Primary DI / UDI-DI
- 18056099646772
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Fluted surgical drill bit, single-use
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
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