OrthoSolutions 'System26' Bone Screws OS900037-NS
by Ortho Solutions Holdings Limited
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055662956108 | Date16 Mar 2017 | StatusListed |
Recalls
-
- Terminated Z-0967-2018
Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- OrthoSolutions 'System26' Bone Screws
- Generic Name
- Cannulated surgical drill bit, single-use
- Model / Ref / Catalog
- OS900037-NS
- Primary DI / UDI-DI
- 05055662956108
- 510(k) Number
- FDA Product Code
- HXY
- GMDN Term
- Cannulated surgical drill bit, single-use
- Device Class
- Class I
- Regulation Number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Ortho Solutions Holdings Limited
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Prescription Use: 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