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Delta 70-05188

by Stryker Leibinger

Ref 70-05188Model 08858251005917U5

Delta 70-05188 is a device classified as Class III in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 08858251005917U5), cleared under FDA 510(k) K213777 on 4 Feb 2022 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04546540337177), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

29 May 2029

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

510(k) K213777

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251005917U5 Basic UDI-DI 04546540337177UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK213777 Date4 Feb 2022DecidedStatusActive
United StatesGUDID listing GUDID Number04546540337177 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251005917U5 registered 9 Oct 2026 Active
  • FDA 510(k) K213777 decided 4 Feb 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04546540337177 listed 24 Sep 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

4 dated events

  1. Cleared FDA 510(k) K993061
  2. Listed FDA GUDID 04546540337177
  3. Cleared FDA 510(k) K213777
  4. Registered EUDAMED 08858251005917U5

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  • Withdrawn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
Delta
Generic name
Craniofacial fixation plate, bioabsorbable
Device name
Delta System Implants
Model / Ref / Catalog
70-05188, 08858251005917U5
Primary DI / UDI-DI
04546540337177
Basic UDI-DI
08858251005917U5
510(k) Number
FDA product code
GXR, JEY, HBW, MAI
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Craniofacial fixation plate, bioabsorbable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5250, 872.4760, 882.5360, 888.3030
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Craniofacial fixation plate, bioabsorbable

Cleared under the same submission (K213777)

and 8 more cleared under K213777

Cleared under the same submission (K993061)

and 8 more cleared under K993061

Other devices from Stryker Leibinger

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    Class II

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  • 92-55771

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  • 92-55770

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See all devices from Stryker Leibinger →

Properties

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