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Indy Standalone 1030-0301A

by Altus Spine

Indy Standalone 1030-0301A is a Class I device made by Altus Spine, cleared under FDA 510(k) K211837 on 19 Apr 2022 and listed in FDA GUDID since 24 Jul 2024 (UDI-DI 00843210172941), active as of 22 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 22 Oct 2026

Documents

510(k) K211837

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843210172941 UDI-DI Date24 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211837 Date19 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211837 decided 19 Apr 2022 Active
  • FDA GUDID UDI-DI 00843210172941 listed 24 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211837
  2. Listed FDA GUDID 00843210172941

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Indy Standalone
Generic name
Surgical screwdriver, reusable
Model / reference
1030-0301A
Primary DI / UDI-DI
00843210172941
510(k) Number
FDA product code
HXX
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Cleared under the same submission (K211837)

and 8 more cleared under K211837

Similar devices in this category

Other devices filed under Surgical screwdriver, reusable.

Other devices from Altus Spine

See all devices from Altus Spine →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)