Optetrak Logic

FDA UDI

Class I (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Optetrak Logic FDA UDI
Generic Name: Knee femur prosthesis trial, reusable FDA UDI
Device Name: LOGIC STEM EXT TRIAL 16MM X 120MM FDA UDI
Model / Reference: 02-013-60-1612 FDA UDI
Description: LOGIC STEM EXT TRIAL 16MM X 120MM FDA UDI

Identifiers

Catalog Number: 02-013-60-1612 FDA UDI
Primary DI / UDI-DI: 10885862285591 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

Yes

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

Dimensions & Sizes

Size: Outer Diameter — 16 Millimeter FDA UDI
Length — 120 Millimeter FDA UDI

Category: Knee femur prosthesis trial, reusable

Optetrak Logic by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee femur prosthesis trial, reusable.

Lospa Modular Knee System — Corentec Co., Ltd · Class II
OSS™ — Biomet Orthopedics, Inc. · Class II
VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
Natural-Knee® — Zimmer, Inc. · Class II
NexGen® — Zimmer, Inc. · Class II
LOSPA Knee System — Corentec Co., Ltd · Class II
Persona® — Zimmer, Inc. · Class II

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 I	Pending data

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

Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 5f74c61d-35dd-451a-91b5-12e3563535ab 35 fields · synced Jun 8, 2026