AlignMATE TM 9B01-5044-A
AlignMATE TM 9B01-5044-A is a Class II device made by Arthrosurface Incorporated, cleared under FDA 510(k) K162391 on 21 Feb 2017 and listed in FDA GUDID since 26 May 2017 (UDI-DI M5289B015044A0), 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 | NumberM5289B015044A0 | Date26 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162391 | Date21 Feb 2017 | StatusActive |
Official records
- FDA 510(k) database K162391
Across registries
- FDA 510(k) K162391 decided 21 Feb 2017 Active
- FDA GUDID UDI-DI M5289B015044A0 listed 26 May 2017 Listed
Timeline
- Cleared FDA 510(k) K162391
- Listed FDA GUDID M5289B015044A0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AlignMATE TM
- Generic name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
- Model / Ref / Catalog
- 9B01-5044-A
- Primary DI / UDI-DI
- M5289B015044A0
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 44 MillimeterOuter Diameter — 4 Millimeter
Similar devices in this category
Other devices filed under Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.