Erisma® LP_navigated Instruments 99780004
Erisma® LP_navigated Instruments 99780004 is a Class II device made by Clariance, Inc., cleared under FDA 510(k) K202956 on 26 Feb 2021 and listed in FDA GUDID since 31 Mar 2021 (UDI-DI 03700780638321), 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 | Number03700780638321 | Date31 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202956 | Date26 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 03700780638321
- FDA 510(k) database K202956
Across registries
- FDA 510(k) K202956 decided 26 Feb 2021 Active
- FDA GUDID UDI-DI 03700780638321 listed 31 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K202956
- Listed FDA GUDID 03700780638321
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Erisma® LP_navigated Instruments
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Model / reference
- 99780004
- Primary DI / UDI-DI
- 03700780638321
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, 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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