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PediFrag System 00-1005-4046

by Orthopediatrics Corp.

Part of a family of 74 devices: see the family page

Ref 00-1005-4046Model 00-1005-4010

PediFrag System 00-1005-4046 is a device classified as Class IIb in the EU and Class II in the US made by Orthopediatrics Corp., registered in EUDAMED on 5 Aug 2026 (Basic UDI-DI 08411321SSCCFTDP), cleared under FDA 510(k) K140431 on 29 Jul 2014 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00841132131800), 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) K140431

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 Number08411321SSCCFTDP Basic UDI-DI 00841132131800UDI-DIDate5 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841132131800 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140431 Date29 Jul 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08411321SSCCFTDP registered 5 Aug 2026 Active
  • FDA 510(k) K140431 decided 29 Jul 2014 Active
  • FDA GUDID UDI-DI 00841132131800 listed 31 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140431
  2. Listed FDA GUDID 00841132131800
  3. Registered EUDAMED 08411321SSCCFTDP

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  • Withdrawn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® Pediloc™ Fragment System EUDAMED
PediFrag System GUDID
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
00-1005-4046, 00-1005-4010
Primary DI / UDI-DI
00841132131800
Basic UDI-DI
08411321SSCCFTDP
510(k) Number
FDA product code
HWC
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic bone screw (non-sliding)
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
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 00841132131800: 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-sliding)

Cleared under the same submission (K140431)

and 8 more cleared under K140431

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
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)