Skip to content

91-16918

by Stryker Leibinger

Ref 91-16918Model 08858251005753TX

91-16918 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 08858251005753TX), cleared under FDA 510(k) K070876 on 27 Apr 2007 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 04546540506702), 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) K070876

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 Number08858251005753TX Basic UDI-DI 04546540506702UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540506702 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 08858251005753TX registered 21 Oct 2026 Active
  • FDA 510(k) K070876 decided 27 Apr 2007 Active
  • FDA GUDID UDI-DI 04546540506702 listed 24 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K070876
  2. Listed FDA GUDID 04546540506702
  3. Registered EUDAMED 08858251005753TX

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  • Withdrawn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 - Mandible and MP Instruments IIa
Model / Ref / Catalog
91-16918, 08858251005753TX
Primary DI / UDI-DI
04546540506702
Basic UDI-DI
08858251005753TX
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 — 29.0 Millimeter
Length — 19.0 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)