Optetrak Logic

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Optetrak Logic FDA UDI
Generic Name: Bone trephine, reusable FDA UDI
Device Name: FEMORAL PS NOTCH CUTTER, LOGIC, SIZE 1 FDA UDI
Model / Reference: 02-019-11-0010 FDA UDI
Description: FEMORAL PS NOTCH CUTTER, LOGIC, SIZE 1 FDA UDI

Identifiers

Catalog Number: 02-019-11-0010 FDA UDI
Primary DI / UDI-DI: 10885862005168 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: Bone trephine, 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

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: Bone trephine, reusable

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

Similar devices

Also classified as Bone trephine, reusable.

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Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
ZOLL-DENTAL — Zoll-Dental · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Borchardt Flat Trephine 5 mm Borchardt Shaft Ø 1.8 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I

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

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: Exactech, Inc.

Sources (1)

FDA UDI 9ac6e481-0ce4-4b32-818e-9ed0a50cb630 36 fields · synced Jun 8, 2026