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Locking Proximal Femur Plate System 00-0907-1203

by Orthopediatrics Corp.

Ref 00-0907-1203Model 00-0907-0102

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321LPFR2 Basic UDI-DI 00841132104156UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132104156 UDI-DI Date1 Aug 2015ListedStatusListed 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  • Withdrawn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 Plate System GUDID
Generic Name
Growth-correction orthopaedic fixation plate kit
Model / Ref / Catalog
00-0907-1203, 00-0907-0102
Primary DI / UDI-DI
00841132104156
Basic UDI-DI
08411321LPFR2
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
EU 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.

See all devices from Orthopediatrics Corp. →

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