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91-10112

by Stryker Leibinger

Ref 91-10112Model 08858251006547TZ

91-10112 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 08858251006547TZ), cleared under FDA 510(k) K070876 on 27 Apr 2007 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 07613153364757), 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) K070876

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 Number08858251006547TZ Basic UDI-DI 07613153364757UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613153364757 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK070876 Date27 Apr 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251006547TZ registered 14 Oct 2026 Active
  • FDA 510(k) K070876 decided 27 Apr 2007 Active
  • FDA GUDID UDI-DI 07613153364757 listed 24 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K070876
  2. Listed FDA GUDID 07613153364757
  3. Registered EUDAMED 08858251006547TZ

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  • Withdrawn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

Generic name
Fluted surgical drill bit, single-use
Device name
Universal Midface Upper-Face and Orbital Floor Class IIa
Model / Ref / Catalog
91-10112, 08858251006547TZ
Primary DI / UDI-DI
07613153364757
Basic UDI-DI
08858251006547TZ
510(k) Number
FDA product code
HBE
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 54.0 Millimeter
Length — 12.0 Millimeter

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: Fluted surgical drill bit, single-use

Cleared under the same submission (K070876)

and 8 more cleared under K070876

Similar devices in this category

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

Other devices from Stryker Leibinger

  • 92-55772

    Class II

  • 92-55773

    Class II

  • 92-55771

    Class II

  • 92-55770

    Class II

See all devices from Stryker Leibinger →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)