Truliant

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Truliant FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Model / Reference: SK-017869 FDA UDI

Identifiers

Catalog Number: SK-017869 FDA UDI
Primary DI / UDI-DI: 10885862578174 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 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: Osteotomy guide, reusable

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

Similar devices

Also classified as Osteotomy guide, reusable.

Legion — Smith & Nephew, Inc. · Class II
MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
Persona® — Zimmer, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Profix — Smith & Nephew, Inc. · Class II
QUANTUM — IN2BONES · Class I
Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Exactech, Inc.

Sources (1)

FDA UDI 2a805c7a-ffaa-449f-80a5-d7c2333042ec 33 fields · synced May 31, 2026