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Indy Standalone SL0013

by Altus Spine

Indy Standalone SL0013 is a Class II device made by Altus Spine, cleared under FDA 510(k) K211837 on 19 Apr 2022 and listed in FDA GUDID since 8 Aug 2024 (UDI-DI 00843210162225), 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) K211837

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 Number00843210162225 UDI-DI Date8 Aug 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 00843210162225 listed 8 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211837
  2. Listed FDA GUDID 00843210162225

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  • Withdrawn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
Lumbar total intervertebral disc prosthesis
Model / reference
SL0013
Primary DI / UDI-DI
00843210162225
510(k) Number
FDA product code
OVD, MAX
GMDN term
Lumbar total intervertebral disc prosthesis
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Lumbar total intervertebral disc prosthesis

Cleared under the same submission (K211837)

and 8 more cleared under K211837

Similar devices

Other devices filed under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Other devices from Altus Spine

See all devices from Altus Spine →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)