FDA.reportPublic FDA data

Catalyst CSR Shoulder System

Primary DI
00851388006784
Brand
Catalyst CSR Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1227-7001-002
Device description
3-Peg Glenoid Implant, Medium
Published
2018-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173812000Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.2018-03-09KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851388006784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851388006784008513880067848513880067840851388006784

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis, prefabricatedAn implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-587-5137ddavison@catalystortho.com

Regulatory Flags#

DUNS number
079702565
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811596032524F1x Fracture Stem System1232-7551-0011232-7551-0012026-08-25
00811596032531F1x Fracture Stem System1232-7551-0021232-7551-0022026-08-25
00811596032548F1x Fracture Stem System1232-7551-0031232-7551-0032026-08-25
00811596032555F1x Fracture Stem System1232-7552-0011232-7552-0012026-08-25
00811596032562F1x Fracture Stem System1232-7552-0021232-7552-0022026-08-25
00811596032579F1x Fracture Stem System1232-7552-0031232-7552-0032026-08-25
00811596032586F1x Fracture Stem System1232-50031232-50032026-08-25
00811596032593F1x Fracture Stem System1232-4005-0021232-4005-0022026-08-25
00811596032609F1x Fracture Stem System1232-4005-0031232-4005-0032026-08-25
00811596032616F1x Fracture Stem System1232-4005-0041232-4005-0042026-08-25
00811596032623F1x Fracture Stem System1232-4005-0051232-4005-0052026-08-25
00811596032630F1x Fracture Stem System1232-4005-0061232-4005-0062026-08-25
00811596032647F1x Fracture Stem System1232-4005-0071232-4005-0072026-08-25
00811596032654F1x Fracture Stem System1232-4005-0081232-4005-0082026-08-25
00811596032661F1x Fracture Stem System1232-4005-0091232-4005-0092026-08-25
00811596032678F1x Fracture Stem System1232-4005-0101232-4005-0102026-08-25
00811596032685F1x Fracture Stem System1232-4005-0111232-4005-0112026-08-25
00811596032982F1x Fracture Stem System1232-4005-0121232-4005-0122026-08-25
00811596032036Reverse Shoulder System1230-52161230-52162026-08-18
00811596032050Reverse Shoulder System1230-7506-0021230-7506-0022026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI270050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI270100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI276000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI278000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
00811596031961CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031978CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031985CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26