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Gorilla Plating System P53-109-1115

by Paragon 28

Ref P53-109-1115

Gorilla Plating System P53-109-1115 is a device classified as Class IIb in the EU and Class II in the US made by Paragon 28, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 0889795P5XIIB01NSUCMNE), cleared under FDA 510(k) K140397 on 17 Apr 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00889795017789), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140397

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0889795P5XIIB01NSUCMNE Basic UDI-DI 00889795017789UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889795017789 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140397 Date17 Apr 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0889795P5XIIB01NSUCMNE registered 5 Nov 2026 Active
  • FDA 510(k) K140397 decided 17 Apr 2014 Active
  • FDA GUDID UDI-DI 00889795017789 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140397
  2. Listed FDA GUDID 00889795017789
  3. Registered EUDAMED 0889795P5XIIB01NSUCMNE

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  • Withdrawn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
Baby Gorilla®/Gorilla® Plating System EUDAMED
Gorilla Plating System GUDID
Generic name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Device name
Baby Gorilla / Gorilla Plating System Implants
Model / Ref / Catalog
P53-109-1115
Primary DI / UDI-DI
00889795017789
Basic UDI-DI
0889795P5XIIB01NSUCMNE
510(k) Number
FDA product code
HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
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: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K140397)

and 8 more cleared under K140397

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Paragon 28

See all devices from Paragon 28 →

Properties

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