FDA.reportPublic FDA data

CSR Shoulder System

Primary DI
00811596030353
Brand
CSR Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1226-5036
Device description
XS Humeral Modular Cut Guide 1
Published
2020-01-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152825000Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC2016-05-11KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811596030353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811596030353008115960303538115960303530811596030353

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guideA non-sterile surgical instrument intended to be attached to a portion of bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure to outline the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, moisture, insects and extremes in temperature and humidity.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
079702565
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811596031404CSR Shoulder System1226-41342021-04-16
00811596030902R1 Reverse Shoulder System1230-42632021-03-03
00811596030919R1 Reverse Shoulder System1230-42562021-03-03
00811596030995R1 Reverse Shoulder System1230-42142021-03-03
00811596031008R1 Reverse Shoulder System1230-52062021-03-03
00811596031015R1 Reverse Shoulder System1230-42172021-03-03
00811596031022R1 Reverse Shoulder System1230-42552021-03-03
00811596031039R1 Reverse Shoulder System1230-42812021-03-03
00811596031046R1 Reverse Shoulder System1230-52042021-03-03
00811596031053R1 Reverse Shoulder System1230-52052021-03-03
00811596031060R1 Reverse Shoulder System1230-52022021-03-03
00811596031077R1 Reverse Shoulder System1230-52112021-03-03
00811596031084R1 Reverse Shoulder System1230-52072021-03-03
00811596031091R1 Reverse Shoulder System1230-52102021-03-03
00811596031107R1 Reverse Shoulder System1230-42222021-03-03
00811596031114R1 Reverse Shoulder System1230-42642021-03-03
00811596031121R1 Reverse Shoulder System1230-42272021-03-03
00811596031138R1 Reverse Shoulder System1230-42262021-03-03
00811596031206R1 Reverse Shoulder System1230-42432021-03-03
00811596031213R1 Reverse Shoulder System1230-42532021-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.HSD2026-05-28
07613327668889Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668896Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
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