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Asy-00397

by Integrity Implants Inc.

Ref ASY-00397

Asy-00397 is a Class I device made by Integrity Implants Inc., registered in EUDAMED on 6 Jun 2022 (Basic UDI-DI B-00810004727939) and listed in FDA GUDID since 12 May 2020 (UDI-DI 00810004727939), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810004727939 Basic UDI-DI 00810004727939UDI-DIDate6 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00810004727939 UDI-DI Date12 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00810004727939 registered 6 Jun 2022 Active
  • FDA GUDID UDI-DI 00810004727939 listed 12 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00810004727939
  2. Registered EUDAMED B-00810004727939

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
FlareHawk Interbody Fusion System
Generic name
Bone curette, reusable
Model / Ref / Catalog
ASY-00397
Primary DI / UDI-DI
00810004727939
Basic UDI-DI
B-00810004727939
FDA product code
LXH
EMDN code
L0901 Orthopaedic surgery spoons and curettes, reusable
GMDN term
Bone curette, reusable
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: Bone curette, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY SPOONS AND CURETTES, 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)