Arcos 31-300565
Arcos 31-300565 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K100469 on 7 Dec 2010 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00880304483996), 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 | Number00880304483996 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100469 | Date7 Dec 2010 | StatusActive |
Official records
- AccessGUDID record 00880304483996
- FDA 510(k) database K100469
Across registries
- FDA 510(k) K100469 decided 7 Dec 2010 Active
- FDA GUDID UDI-DI 00880304483996 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K100469
- Listed FDA GUDID 00880304483996
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arcos
- Generic name
- Bone-resection orthopaedic reamer, reusable
- Model / Ref / Catalog
- 31-300565
- Primary DI / UDI-DI
- 00880304483996
- 510(k) Number
- FDA product code
- LPH, LZO, MEH, JDI, MAY, KWZ, KWY
- GMDN term
- Bone-resection orthopaedic reamer, reusable
- Device class
- Class II
- Regulation number
- 888.3358, 888.3353, 888.3350, 888.3310, 888.3390
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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