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Periacetabular Osteotomy System 01-1401-0003

by Orthopediatrics Corp.

Ref 01-1401-0003Model 01-1401-0001

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321PAOQT Basic UDI-DI 00841132128732UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132128732 UDI-DI Date31 Oct 2016ListedStatusListed 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  • Withdrawn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
Orthopediatrics® Instrumentation EUDAMED
Periacetabular Osteotomy System GUDID
Generic Name
Hand-held surgical retractor, reusable
Model / Ref / Catalog
01-1401-0003, 01-1401-0001
Primary DI / UDI-DI
00841132128732
Basic UDI-DI
08411321PAOQT
FDA Product Code
GAD
EMDN Code
L0915 Spreaders and retractors for orthopaedic surgery, reusable
GMDN Term
Hand-held surgical retractor, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hand-held surgical retractor, reusable

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

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

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: 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