FDA.reportPublic FDA data

Ingen SEVIIN® Shoulder System

Primary DI
B59910148150
Brand
Ingen SEVIIN® Shoulder System
Company
INGEN ORTHOPEDICS, L.L.C.
Model
101-48-15
Catalog number
101-48-15
Device description
HUMERAL HEAD, STANDARD, 48 MM DIA X 15 MM HEIGHT
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
B59910148150PrimaryHIBCC0

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
B59910003010Ingen SEVIIN® Shoulder System100-03-01100-03-012019-03-20
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
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
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
07613327603361REUNIONStryker GmbHKWS2024-10-01
07613327354331REUNIONStryker GmbHKWS2022-11-15
07613327354355REUNIONStryker GmbHKWS2022-11-15
07613327354805REUNIONStryker GmbHKWS2022-11-15
07613327354904REUNIONStryker GmbHKWS2022-11-15
07613327354935REUNIONStryker GmbHKWS2022-11-15
07613327354942REUNIONStryker GmbHKWS2022-11-15
07613327355024REUNIONStryker GmbHKWS2022-11-15
07613327355093REUNIONStryker GmbHKWS2022-11-15
07613327355109REUNIONStryker GmbHKWS2022-11-15
07613327355222REUNIONStryker GmbHKWS2022-11-15
07613327355246REUNIONStryker GmbHKWS2022-11-15
07613327355260REUNIONStryker GmbHKWS2022-11-15
07613327355291REUNIONStryker GmbHKWS2022-11-15
07613327355345REUNIONStryker GmbHKWS2022-11-15
07613327355369REUNIONStryker GmbHKWS2022-11-15
07613327355437REUNIONStryker GmbHKWS2022-11-15
07613327355444REUNIONStryker GmbHKWS2022-11-15
07613327355475REUNIONStryker GmbHKWS2022-11-15
07613327354409REUNIONStryker GmbHKWS2021-04-27
07613327354812REUNIONStryker GmbHKWS2021-04-27
07613327354836REUNIONStryker GmbHKWS2021-04-27
07613327354881REUNIONStryker GmbHKWS2021-04-27
07613327354973REUNIONStryker GmbHKWS2021-04-27
07613327354997REUNIONStryker GmbHKWS2021-04-27
07613327355031REUNIONStryker GmbHKWS2021-04-27
07613327355086REUNIONStryker GmbHKWS2021-04-27
07613327355130REUNIONStryker GmbHKWS2021-04-27
07613327355178REUNIONStryker GmbHKWS2021-04-27