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Valeo 11.007.1150

by CTL Medical Corporation

Valeo 11.007.1150 is a Class II device made by CTL Medical Corporation, cleared under FDA 510(k) K091278 on 28 Jan 2010 and listed in FDA GUDID since 19 Sep 2023 (UDI-DI 00841732159167), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 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 22 Oct 2026

Documents

510(k) K091278

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 Number00841732159167 UDI-DI Date19 Sep 2023ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091278 Date28 Jan 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091278 decided 28 Jan 2010 Active
  • FDA GUDID UDI-DI 00841732159167 listed 19 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091278
  2. Listed FDA GUDID 00841732159167

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Valeo
Generic name
Polymeric spinal interbody fusion cage
Model / reference
11.007.1150
Primary DI / UDI-DI
00841732159167
510(k) Number
FDA product code
MAX, ODP
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K091278)

and 8 more cleared under K091278

Similar devices

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

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)