Kestrel® LS-452
Kestrel® LS-452 is a Class II device made by INNO Holdings, Inc., cleared under FDA 510(k) K181063 on 13 Jul 2018 and listed in FDA GUDID since 30 Sep 2018 (UDI-DI M711LS4520), 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 | NumberM711LS4520 | Date30 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181063 | Date13 Jul 2018 | StatusActive |
Official records
- FDA 510(k) database K181063
Across registries
- FDA 510(k) K181063 decided 13 Jul 2018 Active
- FDA GUDID UDI-DI M711LS4520 listed 30 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K181063
- Listed FDA GUDID M711LS4520
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kestrel®
- Generic name
- Manual orthopaedic bender, reusable
- Model / Ref / Catalog
- LS-452
- Primary DI / UDI-DI
- M711LS4520
- FDA product code
- KWQ
- GMDN term
- Manual orthopaedic bender, reusable
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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