Djo Surgical

FDA UDI

Class I (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: EMP Rev Knee, Symmetric Cone, Diaphyseal Trial, LG FDA UDI
Model / Reference: 800-07-304 FDA UDI
Description: EMP Rev Knee, Symmetric Cone, Diaphyseal Trial, LG FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446845966 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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: Surgical implant template, reusable

Djo Surgical by Encore Medical, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant template, reusable.

Newclip Instruments — NEWCLIP TECHNICS · Class I
Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
Legion — Smith & Nephew, Inc. · Class II
LIGAFIX® — S.B.M. SAS · Class I
EVOS — Smith & Nephew, Inc. · Class I
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
VFT — Ldr Spine USA · Class II
Tranquil-C™ — NEXUS SPINE, L.L.C. · 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 I	Pending data

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

Manufacturer

Manufacturer: Encore Medical, L.p.

Sources (1)

FDA UDI b4173625-a869-4fba-aa15-ed8e82fbc005 33 fields · synced May 31, 2026