FuzeFix Chamfered Screws CD-CS-2035
FuzeFix Chamfered Screws CD-CS-2035 is a Class I device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K170038 on 7 Aug 2017 and listed in FDA GUDID since 10 Nov 2023 (UDI-DI 00840124509337), 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 | Number00840124509337 | Date10 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170038 | Date7 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 00840124509337
- FDA 510(k) database K170038
Across registries
- FDA 510(k) K170038 decided 7 Aug 2017 Active
- FDA GUDID UDI-DI 00840124509337 listed 10 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K170038
- Listed FDA GUDID 00840124509337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FuzeFix Chamfered Screws
- Generic name
- Bone-resection orthopaedic reamer, single-use
- Model / Ref / Catalog
- CD-CS-2035
- Primary DI / UDI-DI
- 00840124509337
- 510(k) Number
- FDA product code
- HTO
- GMDN term
- Bone-resection orthopaedic reamer, single-use
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization