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Exactechgps

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
EXACTECHGPS FDA UDI
Generic Name
Robotic surgical navigation system FDA UDI
Device Name
IMPLANT KIT FDA UDI
Model / Reference
A10007 FDA UDI
Description
IMPLANT KIT FDA UDI

Identifiers

Catalog Number
A10007 FDA UDI
Primary DI / UDI-DI
10885862144294 FDA UDI
510(k) Number
K100742 FDA UDI
K152764 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Robotic surgical navigation 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

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Robotic surgical navigation system

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

Similar devices

Also classified as Robotic surgical navigation system.

Cleared under the same submission

K100742 also covers:

K152764 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 98956d06-8330-4bf0-8c18-325d80dadd96 36 fields · synced May 30, 2026