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AlignMATE™ 9B00-200L-A

by Arthrosurface Incorporated

AlignMATE™ 9B00-200L-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 8 Nov 2018 (UDI-DI M5289B00200LA0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K162391

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM5289B00200LA0 UDI-DI Date8 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK162391 Date21 Feb 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162391 decided 21 Feb 2017 Active
  • FDA GUDID UDI-DI M5289B00200LA0 listed 8 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162391
  2. Listed FDA GUDID M5289B00200LA0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AlignMATE™
Generic name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Model / Ref / Catalog
9B00-200L-A
Primary DI / UDI-DI
M5289B00200LA0
510(k) Number
FDA product code
HRS
GMDN term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Cleared under the same submission (K162391)

and 7 more cleared under K162391

Similar devices in this category

Other devices filed under Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.

Other devices from Arthrosurface Incorporated

See all devices from Arthrosurface Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)