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IJS Drill, Solid Side Cutting, 2.5mm x 80mm

by Skeletal Dynamics L.L.C.

Part of a family of 54 devices: see the family page

Ref DRLL-SSC-25080Model SDRLL-FAM

IJS Drill, Solid Side Cutting, 2.5mm x 80mm (DRLL-SSC-25080) is a device classified as Class IIa in the EU and Class II in the US made by Skeletal Dynamics L.L.C., registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 08415061620565), cleared under FDA 510(k) K153208 on 31 Dec 2015 and listed in FDA GUDID since 30 Oct 2017 (UDI-DI 00841506105222), 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) K153208

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 Number08415061620565 Basic UDI-DI 00841506105222UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841506105222 UDI-DI Date30 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153208 Date31 Dec 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08415061620565 registered 1 Oct 2026 Active
  • FDA 510(k) K153208 decided 31 Dec 2015 Active
  • FDA GUDID UDI-DI 00841506105222 listed 30 Oct 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153208
  2. Listed FDA GUDID 00841506105222
  3. Registered EUDAMED 08415061620565

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  • Withdrawn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
Skeletal Dynamics Single-use Surgical Drills EUDAMED
Ijs GUDID
Generic name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
SDRLL-FAM, DRLL-SSC-25080, Drill, Solid Side Cutting, 2.5mm x 80mm
Primary DI / UDI-DI
00841506105222
Basic UDI-DI
08415061620565
510(k) Number
FDA product code
LXT, OZI
EMDN code
Z12139085 Various orthopaedic and traumatology instruments - consumables
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa 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
Model / referenceEUDAMED
SDRLL-FAM
DRLL-SSC-25080
GUDID
Drill, Solid Side Cutting, 2.5mm x 80mm
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 (K153208)

and 8 more cleared under K153208

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES.

Other devices from Skeletal Dynamics L.L.C.

See all devices from Skeletal Dynamics L.L.C. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)