FDA.reportPublic FDA data

R1 Reverse Shoulder System

Primary DI
00811596030865
Brand
R1 Reverse Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1230-5201
Device description
Stem Handle ASM
Published
2021-03-01
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
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202611000Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.2021-02-12PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811596030865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811596030865008115960308658115960308650811596030865

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. 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
800-587-5137info@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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033390121743SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121804SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
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08033390121835SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121859SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
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08033390121880SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121897SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121910SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121958SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390108065SMR STEMLESSLIMACORPORATE SPAPHX2022-03-17
08033390134392SMR ShoulderLIMACORPORATE SPAPHX2021-11-27
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