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Ijs

FDA UDI

Class II (US FDA UDI)

by Skeletal Dynamics L.l.c.

Identity

Trade Name
IJS FDA UDI
Generic Name
Elbow stabilization implant FDA UDI
Device Name
Double IJS-E, Assembly, Proximal Ulna Plate FDA UDI
Model / Reference
IJS FDA UDI
Description
Double IJS-E, Assembly, Proximal Ulna Plate FDA UDI

Identifiers

Catalog Number
IJS-DBL-PUP FDA UDI
Primary DI / UDI-DI
00841506131559 FDA UDI
510(k) Number
K153208 FDA UDI
FDA Product Code
LXT FDA UDI
OZI FDA UDI
GMDN Term
Elbow stabilization implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Elbow stabilization implant

Ijs by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Elbow stabilization implant.

Cleared under the same submission

K153208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Skeletal Dynamics L.l.c.

Sources (1)

  • FDA UDI 75f92e5d-8f9a-44dc-98ab-d68c892dc898 36 fields · synced May 30, 2026