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PediLoc Tibia 00-0903-3850

by Orthopediatrics Corp.

Ref 00-0903-3850Model 00-0903-3830

PediLoc Tibia 00-0903-3850 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), cleared under FDA 510(k) K111086 on 17 Jun 2011 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00841132129517), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111086

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321SSTPUTLU Basic UDI-DI 00841132129517UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132129517 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111086 Date17 Jun 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08411321SSTPUTLU registered 24 Jul 2026 Active
  • FDA 510(k) K111086 decided 17 Jun 2011 Active
  • FDA GUDID UDI-DI 00841132129517 listed 31 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2796-2015 FDA Class II initiated 28 Jul 2015 on shared 510(k) K111086

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K111086
  2. Recall initiated FDA recalls Z-2796-2015
  3. Listed FDA GUDID 00841132129517
  4. Registered EUDAMED 08411321SSTPUTLU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

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
00-0903-3850, 00-0903-3830
Primary DI / UDI-DI
00841132129517
Basic UDI-DI
08411321SSTPUTLU
510(k) Number
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 00841132129517: 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

Cleared under the same submission (K111086)

and 8 more cleared under K111086

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)