Ijs

FDA UDI

Class II (US FDA UDI)

by Skeletal Dynamics L.l.c.

Identity

Trade Name: IJS FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: IJS-E Axis Guide, Lateral Approach, Md FDA UDI
Model / Reference: IJS-E Axis Guide, Lateral Approach, Md FDA UDI
Description: IJS-E Axis Guide, Lateral Approach, Md FDA UDI

Identifiers

Catalog Number: IJS-EAG-LAM FDA UDI
Primary DI / UDI-DI: 00841506105178 FDA UDI
510(k) Number: K153208 FDA UDI
FDA Product Code: LXT FDA UDI
OZI FDA UDI
GMDN Term: Surgical drill guide, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

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

Similar devices

Also classified as Surgical drill guide, reusable.

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Truliant — Exactech, Inc. · Class II
Vantage — Exactech, Inc. · Class II
Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I
ACUFEX — Smith & Nephew, Inc. · Class I

Cleared under the same submission

K153208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Skeletal Dynamics L.l.c.

Sources (1)

FDA UDI aa61000f-dbe9-4b4c-8606-7b44abb4fccc 36 fields · synced Jun 8, 2026