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Endoskeleton TAS 2312-1111-N

by Titan Spine, Inc.

Endoskeleton TAS 2312-1111-N is a Class II device made by Titan Spine, Inc., cleared under FDA 510(k) K141953 on 27 Oct 2014 (1 earlier submission) and listed in FDA GUDID since 17 Sep 2015 (UDI-DI M68223121111N0), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM68223121111N0 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141953 Date27 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141953 decided 27 Oct 2014 Active· +1 more in the status table
  • FDA GUDID UDI-DI M68223121111N0 listed 17 Sep 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0085-2022 FDA Class II initiated 2 Sep 2021

    Engraving on implants may not match what is listed on the pouch labels.

    • Terminated Z-1440-2021 FDA Class II initiated 17 Mar 2021 on shared 510(k) K141953

    The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K111626
  2. Cleared FDA 510(k) K141953
  3. Listed FDA GUDID M68223121111N0
  4. Recall initiated FDA recalls Z-1440-2021
  5. Recall initiated FDA recalls Z-0085-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Endoskeleton TAS
Generic name
Metallic spinal interbody fusion cage
Model / Ref / Catalog
2312-1111-N
Primary DI / UDI-DI
M68223121111N0
510(k) Number
FDA product code
OVD
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
Not in Commercial Distribution
Size
Height — 11 Millimeter
Angle — 12 degree
Width — 36 Millimeter
Depth — 21 Millimeter

Related devices

Cleared under the same submission (K111626)

and 8 more cleared under K111626

Cleared under the same submission (K141953)

and 2 more cleared under K141953

Similar devices

Other devices filed under FDA product code OVD (Intervertebral fusion device with integrated fixation, lumbar).

Other devices from Titan Spine, Inc.

See all devices from Titan Spine, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)