FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446698371
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
521-09-250
Device description
ALTIVATE ANATOMIC AG, PEGGED GLENOID SZ50, HW-5 RIGHT, EPLUS
Published
2022-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213387000AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.2022-07-07KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446698371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446698371001904466983711904466983710190446698371

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07
00888912025089DJO SURGICAL520-54-1182017-08-07
00888912145114DJO SURGICAL520-42-0162017-08-07
00888912145138DJO SURGICAL520-42-1202017-08-07
00888912145145DJO SURGICAL520-46-0162017-08-07
00888912145152DJO SURGICAL520-46-0202017-08-07
00888912145169DJO SURGICAL520-46-0242017-08-07
00888912145190DJO SURGICAL520-46-1242017-08-07
00888912145206DJO SURGICAL520-50-0182017-08-07
00888912145213DJO SURGICAL520-50-0222017-08-07
00888912145220DJO SURGICAL520-50-0262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862657244EquinoxeExactech, Inc.KWS2026-07-07
10885862657244EquinoxeExactech, Inc.PAO2026-07-07
10885862657251EquinoxeExactech, Inc.PAO2026-07-07
10885862657251EquinoxeExactech, Inc.KWS2026-07-07
10885862657268EquinoxeExactech, Inc.KWS2026-07-07
10885862657268EquinoxeExactech, Inc.PAO2026-07-07
10885862657275EquinoxeExactech, Inc.KWS2026-07-07
10885862657275EquinoxeExactech, Inc.PAO2026-07-07
10885862657282EquinoxeExactech, Inc.PAO2026-07-07
10885862657282EquinoxeExactech, Inc.KWS2026-07-07
10885862657299EquinoxeExactech, Inc.KWS2026-07-07
10885862657299EquinoxeExactech, Inc.PAO2026-07-07
10885862657305EquinoxeExactech, Inc.PAO2026-07-07
10885862657305EquinoxeExactech, Inc.KWS2026-07-07
10885862657312EquinoxeExactech, Inc.PAO2026-07-07
10885862657312EquinoxeExactech, Inc.KWS2026-07-07
10885862657329EquinoxeExactech, Inc.KWS2026-07-07
10885862657329EquinoxeExactech, Inc.PAO2026-07-07
10885862657336EquinoxeExactech, Inc.KWS2026-07-07
10885862657336EquinoxeExactech, Inc.PAO2026-07-07
10885862657343EquinoxeExactech, Inc.KWS2026-07-07
10885862657343EquinoxeExactech, Inc.PAO2026-07-07
10885862657350EquinoxeExactech, Inc.KWS2026-07-07
10885862657350EquinoxeExactech, Inc.PAO2026-07-07
10885862657367EquinoxeExactech, Inc.PAO2026-07-07
10885862657367EquinoxeExactech, Inc.KWS2026-07-07
10885862657374EquinoxeExactech, Inc.PAO2026-07-07
10885862657374EquinoxeExactech, Inc.KWS2026-07-07
10885862657381EquinoxeExactech, Inc.PAO2026-07-07
10885862657381EquinoxeExactech, Inc.KWS2026-07-07