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Orthofix 10-6510-114-00

by AVALIGN TECHNOLOGIES, Inc.

Ref 10-6510-114-00

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 Number0190776RETRACT2N Basic UDI-DI 00190776129507UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776129507 UDI-DI Date10 Mar 2020ListedStatusListed 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  • Withdrawn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
Orthofix
Generic Name
Orthopaedic surgical distractor, internal
Device Name
Palatal Retractor
Model / Reference
10-6510-114-00
Primary DI / UDI-DI
00190776129507
Basic UDI-DI
0190776RETRACT2N
Direct Marketing DI
00190776129507
FDA Product Code
LXH
EMDN Code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN Term
Orthopaedic surgical distractor, internal
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

Related devices

Category: Orthopaedic surgical distractor, internal

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