ExactechGPS Ankle Application

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: ExactechGPS Ankle Application FDA UDI
Generic Name: Orthopaedic stereotactic surgery system FDA UDI
Device Name: Talar Cut Tracker FDA UDI
Model / Reference: 03-GNB-CB-0003 FDA UDI
Description: Talar Cut Tracker FDA UDI

Identifiers

Catalog Number: 03-GNB-CB-0003 FDA UDI
Primary DI / UDI-DI: 10885862631329 FDA UDI
510(k) Number: K232521 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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: Orthopaedic stereotactic surgery system

ExactechGPS Ankle Application by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic stereotactic surgery system.

TRIGEN — Smith & Nephew, Inc. · Class II
PULSE — Nuvasive, Inc. · Class II
KneePlus — PIXEE MEDICAL · Class II
intellijoint HIP® — Intellijoint Surgical Inc · Class II
PULSE — Nuvasive, Inc. · Class II
Navigation Unit Kit — GYDER SURGICAL PTY LTD · Class II
StealthStation S8 Spine — MEDTRONIC NAVIGATION, INC. · Class II
WatchTower — Intai Technology Corporation · Class II

Cleared under the same submission

K232521 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 a9605881-fa93-435d-b721-0d8cfb421978 35 fields · synced May 31, 2026