R1 Reverse Shoulder System

Primary DI
00811596030827
Brand
R1 Reverse Shoulder System
Company
CATALYST ORTHOSCIENCE INC.
Model
1230-5208
Device description
Reamer Drive Shaft
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
00811596030827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811596030827008115960308278115960308270811596030827

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
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
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
05404028001288SurgiCase PlannerMaterialise NVPHX2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncPHX2026-07-10
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-06-26