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Optetrak Logic

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Optetrak Logic FDA UDI
Generic Name
Osteotomy guide, reusable FDA UDI
Device Name
FEMORAL NOTCH GUIDE, LOGIC, SIZE 3.5 FDA UDI
Model / Reference
02-019-10-0035 FDA UDI
Description
FEMORAL NOTCH GUIDE, LOGIC, SIZE 3.5 FDA UDI

Identifiers

Catalog Number
02-019-10-0035 FDA UDI
Primary DI / UDI-DI
10885862005113 FDA UDI
510(k) Number
K033883 FDA UDI
K093360 FDA UDI
K123687 FDA UDI
K140302 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Osteotomy guide, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 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

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: Osteotomy guide, reusable

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

Similar devices

Also classified as Osteotomy guide, reusable.

Cleared under the same submission

K033883 also covers:

K093360 also covers:

K123687 also covers:

K140302 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI 8ebd61a0-c1aa-4b8d-89ec-61c551082cc6 36 fields · synced May 30, 2026