Mountaineer 188318550
Mountaineer 188318550 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K190895 on 18 Jul 2019 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10705034290638), 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 | FDA 510(k) | NumberK190895 | Date18 Jul 2019 | StatusActive |
| United States | GUDID listing | Number10705034290638 | Date24 Sep 2015 | StatusListed |
Official records
- AccessGUDID record 10705034290638
- FDA 510(k) database K190895
- FDA 510(k) database K151885
- FDA 510(k) database K041203
Across registries
- FDA 510(k) K190895 decided 18 Jul 2019 Active
- FDA GUDID UDI-DI 10705034290638 listed 24 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K041203
- Cleared FDA 510(k) K151885
- Listed FDA GUDID 10705034290638
- Cleared FDA 510(k) K190895
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mountaineer
- Generic name
- Spinal bone screw, non-bioabsorbable
- Model / Ref / Catalog
- 188318550
- Primary DI / UDI-DI
- 10705034290638
- FDA product code
- NKG, MNI, KWP
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3075, 888.3070, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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