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Indy FA32241619 FA32241619T

by Altus Spine

Indy FA32241619 FA32241619T is a Class II device made by Altus Spine, cleared under FDA 510(k) K182406 on 22 Feb 2019 and listed in FDA GUDID since 17 Jul 2024 (UDI-DI 00843210137636), 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) K182406

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 Number00843210137636 UDI-DI Date17 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182406 Date22 Feb 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182406 decided 22 Feb 2019 Active
  • FDA GUDID UDI-DI 00843210137636 listed 17 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182406
  2. Listed FDA GUDID 00843210137636

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Indy
Generic name
Spinal implant trial
Model / reference
FA32241619 FA32241619T
Primary DI / UDI-DI
00843210137636
510(k) Number
FDA product code
MAX
GMDN term
Spinal implant trial
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal implant trial

Cleared under the same submission (K182406)

and 8 more cleared under K182406

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Other devices from Altus Spine

See all devices from Altus Spine →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)