FDA.reportPublic FDA data

Ingen SEVIIN® Shoulder System

Primary DI
B59910003010
Brand
Ingen SEVIIN® Shoulder System
Company
INGEN ORTHOPEDICS, L.L.C.
Model
100-03-01
Catalog number
100-03-01
Device description
HUMERAL STEM, SIZE 3 STANDARD, 10 MM DIA X 120 MM LONG
Published
2019-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043346000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043346000GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00Genesis Medical LLC2005-01-31KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B59910003010PrimaryHIBCC0

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
187232066
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B59910001000Ingen SEVIIN® Shoulder System100-01-00100-01-002019-03-20
B59910002010Ingen SEVIIN® Shoulder System100-02-01100-02-012019-03-20
B59910004010Ingen SEVIIN® Shoulder System100-04-01100-04-012019-03-20
B59910005010Ingen SEVIIN® Shoulder System100-05-01100-05-012019-03-20
B59910140150Ingen SEVIIN® Shoulder System101-40-15101-40-152019-03-20
B59910140180Ingen SEVIIN® Shoulder System101-40-18101-40-182019-03-20
B59910140210Ingen SEVIIN® Shoulder System101-40-21101-40-212019-03-20
B59910144150Ingen SEVIIN® Shoulder System101-44-15101-44-152019-03-20
B59910144180Ingen SEVIIN® Shoulder System101-44-18101-44-182019-03-20
B59910144210Ingen SEVIIN® Shoulder System101-44-21101-44-212019-03-20
B59910148150Ingen SEVIIN® Shoulder System101-48-15101-48-152019-03-20
B59910148180Ingen SEVIIN® Shoulder System101-48-18101-48-182019-03-20
B59910148210Ingen SEVIIN® Shoulder System101-48-21101-48-212019-03-20
B59910152150Ingen SEVIIN® Shoulder System101-52-15101-52-152019-03-20
B59910152180Ingen SEVIIN® Shoulder System101-52-18101-52-182019-03-20
B59910152210Ingen SEVIIN® Shoulder System101-52-21101-52-212019-03-20
B59910156150Ingen SEVIIN® Shoulder System101-56-15101-56-152019-03-20
B59910156180Ingen SEVIIN® Shoulder System101-56-18101-56-182019-03-20
B59910156210Ingen SEVIIN® Shoulder System101-56-21101-56-212019-03-20
B59910244180Ingen SEVIIN® Shoulder System102-44-18102-44-182019-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868552113Signature ONE Software PackageOrthosoft IncKWS2026-10-27
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180560Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN190440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN190500Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN200460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN200480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN200520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210500Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210560Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28