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Locking Proximal Femur System 01-1050-0002

by Orthopediatrics Corp.

Ref 01-1050-0002Model 01-1007-0028

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 Number08411321CIIADB3F Basic UDI-DI 00841132122839UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132122839 UDI-DI Date22 Dec 2023ListedStatusListed 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  • Withdrawn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
Locking Proximal Femur System GUDID
Generic Name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
01-1050-0002, 01-1007-0028
Primary DI / UDI-DI
00841132122839
Basic UDI-DI
08411321CIIADB3F
FDA Product Code
GFG
EMDN Code
L99 Surgical instruments, reusable - other
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Fluted surgical drill bit, 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