Headless Compression Screw 110018421
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00887868138706 | Date24 Oct 2015 | StatusListed |
Recalls
-
- Terminated Z-1302-2019
- Terminated Z-1303-2019
There is a potential of fracture, bending or shearing of the driver.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Headless Compression Screw
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
- Model / Ref / Catalog
- 110018421
- Primary DI / UDI-DI
- 00887868138706
- 510(k) Number
- FDA Product Code
- HWC
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
- Device Class
- Class II
- Regulation Number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No