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PNP Tibia 01-1510-0012-S

by Orthopediatrics Corp.

Ref 01-1510-0012-SModel 01-1510-0011-S

PNP Tibia 01-1510-0012-S is a device classified as Class IIa in the EU and Class I in the US made by Orthopediatrics Corp., registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI 08411321CIIAPU5R) and listed in FDA GUDID since 28 May 2025 (UDI-DI 00840194472579), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08411321CIIAPU5R Basic UDI-DI 00840194472579UDI-DIDate23 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840194472579 UDI-DI Date28 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08411321CIIAPU5R registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI 00840194472579 listed 28 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840194472579
  2. Registered EUDAMED 08411321CIIAPU5R

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  • Withdrawn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® Instrumentation EUDAMED
PNP Tibia GUDID
Generic name
Bone-coring punch, reusable
Device name
Proximal Tibial Punch, 11mm, Short
Model / Ref / Catalog
01-1510-0012-S, 01-1510-0011-S
Primary DI / UDI-DI
00840194472579
Basic UDI-DI
08411321CIIAPU5R
FDA product code
LRY
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Bone-coring punch, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Bone-coring punch, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Orthopediatrics Corp.

See all devices from Orthopediatrics Corp. →

Properties

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