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Locking Proximal Femur 00-1050-6208

by Orthopediatrics Corp.

Ref 00-1050-6208Model 00-1050-5003

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321DFOSE6 Basic UDI-DI 00841132130131UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132130131 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.

Recalls

1 recall · FDA

    • Terminated Z-2796-2015 FDA Class II initiated 28 Jul 2015

    The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.

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  • Withdrawn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® Locking Proximal Femur Plate System Distal Femoral Osteotomy System EUDAMED
Locking Proximal Femur GUDID
Generic Name
Growth-correction orthopaedic fixation plate kit
Model / Ref / Catalog
00-1050-6208, 00-1050-5003
Primary DI / UDI-DI
00841132130131
Basic UDI-DI
08411321DFOSE6
510(k) Number
FDA Product Code
HRS
EMDN Code
P09120503 Osteosynthesis screw-plate systems
GMDN Term
Growth-correction orthopaedic fixation plate kit
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Growth-correction orthopaedic fixation plate kit

Cleared under the same submission (K111086)

Show all (12)

Other devices from Orthopediatrics Corp.

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Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No