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Alphatec Spine 89000-11-035

by AVALIGN TECHNOLOGIES, Inc.

Ref 89000-08-016

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190776SCRAPVZ Basic UDI-DI 00190776149048UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776149048 UDI-DI Date10 Apr 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Alphatec Spine
Generic Name
Bone file/rasp, manual, reusable
Device Name
Lat 4mm Straight Curette
Model / Reference
89000-08-016 EUDAMED
89000-11-035 GUDID
Primary DI / UDI-DI
00190776149048
Basic UDI-DI
0190776SCRAPVZ
Direct Marketing DI
00190776149048
FDA Product Code
LXH
EMDN Code
L091201 Orthopaedic surgery rasps, reusable
GMDN Term
Bone file/rasp, manual, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Angle — 35 degree

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
89000-08-016
GUDID
89000-11-035

Related devices

Category: Bone file/rasp, manual, reusable

Other devices from AVALIGN TECHNOLOGIES, Inc.

See all devices from AVALIGN TECHNOLOGIES, Inc. →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No