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VALEO II TL Interbody Fusion System 12.401.1015

by CTL Medical Corporation

VALEO II TL Interbody Fusion System 12.401.1015 is a Class II device made by CTL Medical Corporation, cleared under FDA 510(k) K121892 on 24 Aug 2012 (1 earlier submission) and listed in FDA GUDID since 27 Sep 2023 (UDI-DI 00841732157255), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841732157255 UDI-DI Date27 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK121892 Date24 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121892 decided 24 Aug 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841732157255 listed 27 Sep 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082801
  2. Cleared FDA 510(k) K121892
  3. Listed FDA GUDID 00841732157255

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VALEO II TL Interbody Fusion System
Generic name
Ceramic spinal interbody fusion cage
Model / reference
12.401.1015
Primary DI / UDI-DI
00841732157255
510(k) Number
FDA product code
ODP, MAX
GMDN term
Ceramic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K082801)

and 8 more cleared under K082801

Cleared under the same submission (K121892)

and 8 more cleared under K121892

Similar devices

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

Other devices from CTL Medical Corporation

See all devices from CTL Medical Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)