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Truliant

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
Truliant FDA UDI
Generic Name
Knee arthroplasty force sensor balance kit FDA UDI
Device Name
Special LBS III Femoral Paddle Extension, Right FDA UDI
Model / Reference
SPI-010786 FDA UDI
Description
Special LBS III Femoral Paddle Extension, Right FDA UDI

Identifiers

Catalog Number
SPI-010786 FDA UDI
Primary DI / UDI-DI
10885862650467 FDA UDI
510(k) Number
K033883 FDA UDI
K093360 FDA UDI
K111400 FDA UDI
K123687 FDA UDI
K140302 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Knee arthroplasty force sensor balance kit 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Knee arthroplasty force sensor balance kit

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

Similar devices

Also classified as Knee arthroplasty force sensor balance kit.

Cleared under the same submission

K033883 also covers:

K093360 also covers:

K111400 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 1d1a3326-9c69-45ba-86ab-a4ec1b8b4082 35 fields · synced May 31, 2026