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Truliant

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Truliant FDA UDI
Generic Name
Surgical optical-tracking spatial marker, reusable FDA UDI
Model / Reference
02-521-20-1005 FDA UDI

Identifiers

Catalog Number
02-521-20-1005 FDA UDI
Primary DI / UDI-DI
10885862604798 FDA UDI
510(k) Number
K152764 FDA UDI
K193618 FDA UDI
K213877 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Surgical optical-tracking spatial marker, reusable 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

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: Surgical optical-tracking spatial marker, reusable

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

Similar devices

Also classified as Surgical optical-tracking spatial marker, reusable.

Cleared under the same submission

K152764 also covers:

K193618 also covers:

K213877 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 756c5a90-00aa-4d10-b852-c61810ca7b5e 34 fields · synced Jun 8, 2026