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Jts Extendible Distal Femoral Implant

FDA UDI

Class II (US FDA UDI)

by Onkos Surgical, Inc.

Identity

Trade Name
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT FDA UDI
Generic Name
Extremity MRI system, resistive magnet FDA UDI
Device Name
JTS Drive Unit Set FDA UDI
Model / Reference
MLE3 FDA UDI
Description
JTS Drive Unit Set FDA UDI

Identifiers

Catalog Number
JTS-DRIVE-UNIT FDA UDI
Primary DI / UDI-DI
B278JTSDRIVEUNIT0 FDA UDI
510(k) Number
K092138 FDA UDI
FDA Product Code
KRO FDA UDI
GMDN Term
Extremity MRI system, resistive magnet FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3510 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Extremity MRI system, resistive magnet

Jts Extendible Distal Femoral Implant by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K092138 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Onkos Surgical, Inc.

Sources (1)

  • FDA UDI af45b7c3-9705-4910-8686-989edd728df6 35 fields · synced May 30, 2026