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VALEO C Spacer System 11.009.1012

by CTL Medical Corporation

VALEO C Spacer System 11.009.1012 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 00841732154575), 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

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 Number00841732154575 UDI-DI Date19 Sep 2023ListedStatusListed GUDID: 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 00841732154575 listed 19 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091278
  2. Listed FDA GUDID 00841732154575

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VALEO C Spacer System
Generic name
Ceramic spinal interbody fusion cage
Model / reference
11.009.1012
Primary DI / UDI-DI
00841732154575
510(k) Number
FDA product code
ODP
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 (K091278)

and 8 more cleared under K091278

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)