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 AG, PEGGED GLENOID SZ38, SYMMETRIC, E-PLUS FDA UDI
Model / Reference: 521-09-038 FDA UDI
Description: ALTIVATE ANATOMIC AG, PEGGED GLENOID SZ38, SYMMETRIC, E-PLUS FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446698265 FDA UDI
510(k) Number: K213387 FDA UDI
FDA Product Code: KWS FDA UDI
PAO FDA UDI
GMDN Term: Total 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 shoulder prosthesis

A comprehensive 2-3 paragraph SEO description written in clear, natural language. DO NOT INCLUDE ANY JSON HERE.

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

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

Manufacturer

Manufacturer: Encore Medical, L.p.

Sources (1)

FDA UDI d495733c-a797-41a4-8db6-3977d66638fa 34 fields · synced Jul 17, 2026