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1320-8201

by Stryker GmbH

Ref 1320-8201Model 08858251003013S2

1320-8201 is a device classified as Class IIa in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 28 Jul 2026 (Basic UDI-DI 08858251003013S2), cleared under FDA 510(k) K173946 on 2 May 2018 and listed in FDA GUDID since 14 Sep 2018 (UDI-DI 07613327298192), active as of 12 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173946

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003013S2 Basic UDI-DI 07613327298192UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327298192 UDI-DI Date14 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173946 Date2 May 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251003013S2 registered 28 Jul 2026 Active
  • FDA 510(k) K173946 decided 2 May 2018 Active
  • FDA GUDID UDI-DI 07613327298192 listed 14 Sep 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173946
  2. Listed FDA GUDID 07613327298192
  3. Registered EUDAMED 08858251003013S2

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  • Withdrawn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
Gamma3®
Generic name
Medical image management system
Device name
GAMMA3 Instruments - Handles and Adaptors - Class Iia - Non Sterile
Model / Ref / Catalog
1320-8201, 08858251003013S2
Primary DI / UDI-DI
07613327298192
Basic UDI-DI
08858251003013S2
Direct marketing DI
07613327298192
FDA product code
OLO
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Medical image management system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Medical image management system

Cleared under the same submission (K173946)

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)