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PediLoc Tibia 00-0903-3934

by Orthopediatrics Corp.

Part of a family of 42 devices: see the family page

Ref 00-0903-3934Model 00-0903-3830

PediLoc Tibia 00-0903-3934 is a device classified as Class IIb in the EU and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 08411321SSTPUTLU) and listed in FDA GUDID since 30 Jul 2017 (UDI-DI 00841132137949), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321SSTPUTLU Basic UDI-DI 00841132137949UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132137949 UDI-DI Date30 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08411321SSTPUTLU registered 24 Jul 2026 Active
  • FDA GUDID UDI-DI 00841132137949 listed 30 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841132137949
  2. Registered EUDAMED 08411321SSTPUTLU

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  • Withdrawn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;orthopediatrics® Locking Cannulated Blade Plate System EUDAMED
PediLoc Tibia GUDID
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Ref / Catalog
00-0903-3934, 00-0903-3830
Primary DI / UDI-DI
00841132137949
Basic UDI-DI
08411321SSTPUTLU
FDA product code
HWC
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No
ImplantableEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00841132137949: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)