20-8011-013-51
20-8011-013-51 is a Class II device made by Orthosoft Inc, cleared under FDA 510(k) K141601 on 11 Sep 2014 and listed in FDA GUDID since 12 Sep 2017 (UDI-DI 00889024492721), active as of 22 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 | Number00889024492721 | Date12 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141601 | Date11 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 00889024492721
- FDA 510(k) database K141601
Across registries
- FDA 510(k) K141601 decided 11 Sep 2014 Active
- FDA GUDID UDI-DI 00889024492721 listed 12 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K141601
- Listed FDA GUDID 00889024492721
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / reference
- 20-8011-013-51
- Primary DI / UDI-DI
- 00889024492721
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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