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Ijs-E

by Skeletal Dynamics L.L.C. 7 variants

Ijs-E (IJS-PUP-BPA) is a Class II device made by Skeletal Dynamics L.L.C., listed in FDA GUDID since 20 Jun 2023 (UDI-DI 00841506109107), registry data as of 31 May 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841506109107 UDI-DI Date20 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Elbow stabilization implant
Model / Ref / Catalog
IJS, IJS-PUP-BPA
Primary DI / UDI-DI
00841506109107
FDA product code
OZI, LXT
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

Similar devices

Other devices filed under FDA product code LXT.

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)