FDA.reportPublic FDA data

R1 Reverse Shoulder System

Primary DI
00811596030643
Brand
R1 Reverse Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1230-7511-006
Device description
Peripheral Screw 4.5mm - 32mm
Published
2021-02-28
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

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
00811596030643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811596030643008115960306438115960306430811596030643

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

Contacts#

Phone, Email table
PhoneEmail
800-587-5137info@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
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
08033390115698SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121712SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121736SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121743SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121804SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121828SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121835SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121859SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121873SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
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
07613327507096REUNIONStryker GmbHPHX2021-11-02
07613327354317REUNIONStryker GmbHPHX2021-04-27
07613327354348REUNIONStryker GmbHPHX2021-04-27
07613327354362REUNIONStryker GmbHPHX2021-04-27
07613327354393REUNIONStryker GmbHPHX2021-04-27
07613327354409REUNIONStryker GmbHPHX2021-04-27
07613327354782REUNIONStryker GmbHPHX2021-04-27
07613327354812REUNIONStryker GmbHPHX2021-04-27
07613327354829REUNIONStryker GmbHPHX2021-04-27
07613327354836REUNIONStryker GmbHPHX2021-04-27
07613327354881REUNIONStryker GmbHPHX2021-04-27
07613327354911REUNIONStryker GmbHPHX2021-04-27
07613327354928REUNIONStryker GmbHPHX2021-04-27
07613327354959REUNIONStryker GmbHPHX2021-04-27
07613327354966REUNIONStryker GmbHPHX2021-04-27