FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446257622
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
509-03-436
Device description
AR, SMALL SOCKET INSERT, 36MM SEMI CONSTRAINED +4 Eplus
Published
2017-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172351000AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket InsertEncore Medical L.P.2017-10-30KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446257622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446257622001904462576221904462576220190446257622

GMDN Terms#

Term, Definition table
TermDefinition
Total reverse shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted 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
00190446776550DJO SURGICAL800-99-1632025-01-17
00190446776567DJO SURGICAL800-99-1642025-01-17
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446706304DJO SURGICAL800-99-1482022-10-18
00190446706311DJO SURGICAL800-99-1492022-10-18
00190446706328DJO SURGICAL800-99-1512022-10-18
00190446706335DJO SURGICAL800-99-1522022-10-18
00190446757665DJO SURGICAL800-99-1592022-08-17
00190446757672DJO SURGICAL800-99-1602022-08-17
00190446764274DJO SURGICAL800-99-1612022-08-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSPHX2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533919Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18