Engage Partial Knee System

FDA UDI

Class II (US FDA UDI)

by Engage Uni, LLC

Identity

Trade Name: Engage Partial Knee System FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Device Name: Tibial Cutting Block 0MM Left Medial FDA UDI
Model / Reference: 1-50010-000 FDA UDI
Description: Tibial Cutting Block 0MM Left Medial FDA UDI

Identifiers

Primary DI / UDI-DI: B6951500100000 FDA UDI
510(k) Number: K190439 FDA UDI
FDA Product Code: NJD FDA UDI
HSX FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3535 FDA UDI
888.3520 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: Joint prosthesis implantation kit, reusable

Engage Partial Knee System by Engage Uni, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Joint prosthesis implantation kit, reusable.

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IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
Evolution — MicroPort Orthopedics Inc. · Class II
GUARDIAN® — MicroPort Orthopedics Inc. · Class I
ADVANCE® — MicroPort Orthopedics Inc. · Class I
PROPHECY — MicroPort Orthopedics Inc. · Class II

Cleared under the same submission

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: Engage Uni, LLC

Sources (1)

FDA UDI af472c0e-937e-4b4f-955c-3e41581df21a 35 fields · synced May 30, 2026