← Back to catalogue

Klassic Stem Adapter, Femoral

FDA UDI

Class II (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name
Klassic Stem Adapter, Femoral FDA UDI
Generic Name
Knee femur stem/sleeve connector FDA UDI
Device Name
Stem Adapter, Femoral FDA UDI
Model / Reference
6602.00.000 FDA UDI
Description
Stem Adapter, Femoral FDA UDI

Identifiers

Primary DI / UDI-DI
00814703019654 FDA UDI
510(k) Number
K230537 FDA UDI
FDA Product Code
MBH FDA UDI
JWH FDA UDI
OIY FDA UDI
GMDN Term
Knee femur stem/sleeve connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3565 FDA UDI
888.3560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Knee femur stem/sleeve connector

Klassic Stem Adapter, Femoral by Total Joint Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee femur stem/sleeve connector.

Cleared under the same submission

K230537 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Total Joint Orthopedics, Inc.

Sources (1)

  • FDA UDI fc249648-5bfb-46e4-8ae3-c539153f84c0 36 fields · synced May 30, 2026