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Ijs

by Skeletal Dynamics L.L.C. 8 variants

Part of a family of 99 devices: see the family page

Ref IJS-EAG-LLModel GUIDE-FAM

Ijs (IJS-EAG-LL) is a device classified as Class I in the EU and Class II in the US made by Skeletal Dynamics L.L.C., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 0841506140045B), cleared under FDA 510(k) K153208 on 31 Dec 2015 and listed in FDA GUDID since 20 Jun 2023 (UDI-DI 00841506132945), active as of 7 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 7 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 7 Oct 2026.

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841506140045B Basic UDI-DI 00841506132945UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841506132945 UDI-DI Date20 Jun 2023ListedStatusListed 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 0841506140045B registered 2 Sep 2026 Active
  • FDA 510(k) K153208 decided 31 Dec 2015 Active
  • FDA GUDID UDI-DI 00841506132945 listed 20 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153208
  2. Listed FDA GUDID 00841506132945
  3. Registered EUDAMED 0841506140045B

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  • Withdrawn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 Guides EUDAMED
Ijs GUDID
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
GUIDE-FAM, IJS-EAG-LL, IJS
Primary DI / UDI-DI
00841506132945
Basic UDI-DI
0841506140045B
510(k) Number
FDA product code
OZI, LXT
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Surgical drill guide, reusable
Device class
Class I 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
GUIDE-FAM
IJS-EAG-LL
GUDID
IJS
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Surgical drill guide, reusable

Cleared under the same submission (K153208)

and 8 more cleared under K153208

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from Skeletal Dynamics L.L.C.

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

Properties

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