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Ii-1-0312

by Integrity Implants Inc.

Ref II-1-0312

Ii-1-0312 is a Class I device made by Integrity Implants Inc., registered in EUDAMED on 15 Jun 2022 (Basic UDI-DI B-00850231007923) and listed in FDA GUDID since 30 Jan 2017 (UDI-DI 00850231007923), withdrawn as of 22 Oct 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850231007923 Basic UDI-DI 00850231007923UDI-DIDate15 Jun 2022RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00850231007923 UDI-DI Date30 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850231007923 registered 15 Jun 2022 Withdrawn
  • FDA GUDID UDI-DI 00850231007923 listed 30 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850231007923
  2. Registered EUDAMED B-00850231007923

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
FlareHawk Interbody Fusion System
Generic name
Orthopaedic surgical distractor, internal
Model / Ref / Catalog
II-1-0312
Primary DI / UDI-DI
00850231007923
Basic UDI-DI
B-00850231007923
FDA product code
LXH
EMDN code
L0920 Orthopaedic surgery distractors, reusable
GMDN term
Orthopaedic surgical distractor, internal
Device class
Class I
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical distractor, internal

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE.

Other devices from Integrity Implants Inc.

See all devices from Integrity Implants Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (18, all answered No)