Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Total shoulder prosthesis FDA UDI
Device Name: AltiVate Anatomic, Short Humeral Stem, 16mm FDA UDI
Model / Reference: 520-16-000 FDA UDI
Description: AltiVate Anatomic, Short Humeral Stem, 16mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446176046 FDA UDI
510(k) Number: K162024 FDA UDI
FDA Product Code: PAO FDA UDI
HSD FDA UDI
KWS FDA UDI
GMDN Term: Total shoulder prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3690 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 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 shoulder prosthesis.

B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC. · Class II
Shoulder Innovations Humeral Stemless System — SHOULDER INNOVATIONS, Inc · Class II
Shoulder Innovations Inset Reverse Total Shoulder — SHOULDER INNOVATIONS, Inc · Class II
Shoulder System — Medacta International · Class II
Arthrex® — Arthrex, Inc. · Class II
PROMOS — Smith & Nephew, Inc. · Class II
LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
REUNION — Stryker Corp. · 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: Encore Medical, L.p.

Sources (1)

FDA UDI 8e7584da-f772-49c9-ad84-067aebe38599 34 fields · synced May 30, 2026