Catalyst CSR Shoulder System

Primary DI
00851388006777
Brand
Catalyst CSR Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1227-7001-001
Device description
3-Peg Glenoid Implant, Small
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
00851388006777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851388006777008513880067778513880067770851388006777

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
00811596031886Reverse Shoulder System1230-7523-0011230-7523-0012026-07-17
00811596031893Reverse Shoulder System1230-7523-0021230-7523-0022026-07-17
00811596031909Reverse Shoulder System1230-7524-0011230-7524-0012026-07-17
00811596031916Reverse Shoulder System1230-7524-0021230-7524-0022026-07-17
00811596031923Reverse Shoulder System1230-7513-0031230-7513-0032026-07-17
00811596031930Reverse Shoulder System1230-7514-0031230-7514-0032026-07-17
00811596031947Reverse Shoulder System1230-7525-0011230-7525-0012026-07-17
00811596031954Reverse Shoulder System1230-43131230-43132026-07-17
00811596031961CSR Shoulder System1226-5038-0011226-5038-0012026-07-17
00811596031978CSR Shoulder System1226-5038-0021226-5038-0022026-07-17
00811596031985CSR Shoulder System1226-5038-0031226-5038-0032026-07-17
00811596031992EA Convertible System1231-46051231-46052026-07-17
00811596032005Reverse Shoulder System1230-4224-0031230-4224-0032026-07-17
00811596032012Reverse Shoulder System1230-4225-0031230-4225-0032026-07-17
00811596031695EA Convertible System1231-4601-0011231-4601-0012026-07-14
00811596031701EA Convertible System1231-4601-0021231-4601-0022026-07-14
00811596031718EA Convertible System1231-4601-0031231-4601-0032026-07-14
00811596031725EA Convertible System1231-4601-0041231-4601-0042026-07-14
00811596031732EA Convertible System1231-4601-005231-4601-0052026-07-14
00811596031749EA Convertible System1231-4601-0061231-4601-0062026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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