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PNP Tibia 00-1524-5475-S

by Orthopediatrics Corp.

Ref 00-1524-5475-SModel 00-1524-0015

PNP Tibia 00-1524-5475-S is a device classified as Class IIb in the EU and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 084113211510TiSCREWHS), cleared under FDA 510(k) K250623 on 1 Apr 2025 and listed in FDA GUDID since 28 May 2025 (UDI-DI 00840194470179), 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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250623

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 Number084113211510TiSCREWHS Basic UDI-DI 00840194470179UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840194470179 UDI-DI Date28 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK250623 Date1 Apr 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 084113211510TiSCREWHS registered 21 Sep 2026 Active
  • FDA 510(k) K250623 decided 1 Apr 2025 Active
  • FDA GUDID UDI-DI 00840194470179 listed 28 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250623
  2. Listed FDA GUDID 00840194470179
  3. Registered EUDAMED 084113211510TiSCREWHS

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  • Withdrawn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 Pediatrics Nailing Platform|Tibia System EUDAMED
PNP Tibia GUDID
Generic name
Orthopaedic bone screw (non-sliding)
Device name
PNP 4.0mm x 15mm Fully Threaded Screw, Ti
Model / Ref / Catalog
00-1524-5475-S, 00-1524-0015
Primary DI / UDI-DI
00840194470179
Basic UDI-DI
084113211510TiSCREWHS
510(k) Number
FDA product code
HSB
EMDN code
P09120604 Osteosynthesis nail-screw systems
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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-sliding)

Cleared under the same submission (K250623)

and 8 more cleared under K250623

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS NAIL-SCREW SYSTEMS.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)