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Idys™- LIF 06533308-S

by Clariance, Inc.

Ref 06533308-SModel Idys® TLIF

Idys™- LIF 06533308-S is a device classified as Class IIb in the EU and Class II in the US made by Clariance, Inc., registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI B-03700780603756), cleared under FDA 510(k) K131178 on 10 Oct 2013 and listed in FDA GUDID since 23 Oct 2015 (UDI-DI 03700780603756), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131178

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03700780603756 Basic UDI-DI 03700780603756UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700780603756 UDI-DI Date23 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131178 Date10 Oct 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03700780603756 registered 30 Jun 2026 Active
  • FDA 510(k) K131178 decided 10 Oct 2013 Active
  • FDA GUDID UDI-DI 03700780603756 listed 23 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131178
  2. Listed FDA GUDID 03700780603756
  3. Registered EUDAMED B-03700780603756

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Cage Tlif (W33 D12 H08 Mm) EUDAMED
Idys™- LIF GUDID
Generic name
Polymeric spinal fusion cage, sterile
Model / Ref / Catalog
06533308-S, Idys® TLIF
Primary DI / UDI-DI
03700780603756
Basic UDI-DI
B-03700780603756
510(k) Number
FDA product code
MAX
EMDN code
P09070101 Spinal cages
GMDN term
Polymeric spinal fusion cage, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3080
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Height — 8 Millimeter
Depth — 12 Millimeter
Width — 33 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Polymeric spinal fusion cage, sterile

Cleared under the same submission (K131178)

and 8 more cleared under K131178

Similar devices in this category

Other devices filed under SPINAL CAGES.

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)