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Ijs

by Skeletal Dynamics L.L.C. 20 variants

Ijs (IJS-DBL-PUP) is a Class II device made by Skeletal Dynamics L.L.C., cleared under FDA 510(k) K153208 on 31 Dec 2015 and listed in FDA GUDID since 20 Jun 2023 (UDI-DI 00841506131559), active as of 21 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

510(k) K153208

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841506131559 UDI-DI Date20 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153208 Date31 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153208 decided 31 Dec 2015 Active
  • FDA GUDID UDI-DI 00841506131559 listed 20 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153208
  2. Listed FDA GUDID 00841506131559

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Elbow stabilization implant
Model / Ref / Catalog
IJS, IJS-DBL-PUP
Primary DI / UDI-DI
00841506131559
510(k) Number
FDA product code
LXT, OZI
GMDN term
Elbow stabilization implant
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Elbow stabilization implant

Cleared under the same submission (K153208)

and 8 more cleared under K153208

Similar devices

Also classified as Elbow stabilization implant.

Similar devices

Other devices filed under FDA product code LXT (APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE).

Other devices from Skeletal Dynamics L.L.C.

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

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)