FDA.reportPublic FDA data

Ingen SEVIIN® Shoulder System

Primary DI
B59910536130
Brand
Ingen SEVIIN® Shoulder System
Company
INGEN ORTHOPEDICS, L.L.C.
Model
105-36-13
Catalog number
105-36-13
Device description
REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +3 MM
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
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120374000SEVIIN REVERSE SHOULDERIngen Orthopedics, LLC2012-07-09PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B59910536130PrimaryHIBCC0

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
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
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

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Primary DI, Brand, Company table
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00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
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00811596032562F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032579F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
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00811596032593F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032609F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032616F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032623F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032630F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032647F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032654F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032661F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
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