Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Total reverse shoulder prosthesis FDA UDI
Device Name: ALTIVATE ANTAOMIC TO REVERSE CONVERSION MODULE, NEUTRAL FDA UDI
Model / Reference: 508-07-000 FDA UDI
Description: ALTIVATE ANTAOMIC TO REVERSE CONVERSION MODULE, NEUTRAL FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446259039 FDA UDI
510(k) Number: K173073 FDA UDI
FDA Product Code: PHX FDA UDI
KWS FDA UDI
PAO FDA UDI
GMDN Term: Total reverse shoulder prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total reverse shoulder prosthesis

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

Similar devices

Also classified as Total reverse shoulder prosthesis.

Anatomical Shoulder# — Zimmer, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Shoulder Innovations Inset Reverse Total Shoulder — SHOULDER INNOVATIONS, Inc · Class II
R1 Reverse Shoulder System — CATALYST ORTHOSCIENCE Inc · Class II
DELTA XTEND — DEPUY (IRELAND) · Class II
Tornier Flex Shoulder System — TORNIER, INC. · Class II
AEQUALIS REVERSED FRACTURE — TORNIER, INC. · Class II

Cleared under the same submission

K173073 also covers:

DJO SURGICAL — ENCORE MEDICAL, L.P.

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: Encore Medical, L.p.

Sources (1)

FDA UDI 5c67ab55-c492-4996-926c-6a0b3ba8cf95 34 fields · synced May 30, 2026