Erisma™-LP 18019575
Erisma™-LP 18019575 is a Class II device made by Clariance, Inc., cleared under FDA 510(k) K120469 on 13 Aug 2012 and listed in FDA GUDID since 22 Sep 2014 (UDI-DI 03700780605613), 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 | Number03700780605613 | Date22 Sep 2014 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120469 | Date13 Aug 2012 | StatusActive |
Official records
- AccessGUDID record 03700780605613
- FDA 510(k) database K120469
Across registries
- FDA 510(k) K120469 decided 13 Aug 2012 Active
- FDA GUDID UDI-DI 03700780605613 listed 22 Sep 2014 Listed
Timeline
- Cleared FDA 510(k) K120469
- Listed FDA GUDID 03700780605613
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Erisma™-LP
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / Ref / Catalog
- 18019575
- Primary DI / UDI-DI
- 03700780605613
- 510(k) Number
- FDA product code
- NKB, MNH, MNI
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 75 MillimeterOuter Diameter — 9.5 Millimeter
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