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Endoskeleton TAS 2312-0112

by Titan Spine, Inc.

Endoskeleton TAS 2312-0112 is a Class II device made by Titan Spine, Inc., cleared under FDA 510(k) K111626 on 9 Sep 2011 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI M682231201120), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

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 found

in data synced 23 Oct 2026

Documents

510(k) K111626

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 NumberM682231201120 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111626 Date9 Sep 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111626 decided 9 Sep 2011 Active
  • FDA GUDID UDI-DI M682231201120 listed 17 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111626
  2. Listed FDA GUDID M682231201120

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  • Withdrawn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
2312-0112
Primary DI / UDI-DI
M682231201120
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
Sterilisation method
Moist Heat or Steam Sterilization
Size
Width — 32 Millimeter
Angle — 12 degree
Depth — 21 Millimeter
Height — 12 Millimeter

Related devices

Cleared under the same submission (K111626)

and 8 more cleared under K111626

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

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