FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867352247
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9581-2835-2S
Catalog number
AR-9581-2835-2S
Device description
28MM BASEPLATE, 35° HALF AUG, +2 LAT, ST
Published
2023-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867352247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867352247008888673522478888673522470888867352247

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis base plateA sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867614956Arthrex®AR-S8457EXCAR-S8457EXC2026-05-25
00888867531949Arthrex®AR-8827H-22SAR-8827H-22S2026-03-16
00888867531970Arthrex®AR-8827H-28SAR-8827H-28S2026-03-16
00888867531987Arthrex®AR-8827H-30SAR-8827H-30S2026-03-16
00888867532014Arthrex®AR-8827H-36SAR-8827H-36S2026-03-16
00888867134874Arthrex®AR-9104-04AR-9104-042017-02-15
00888867336506Arthrex®AR-1593-4AR-1593-42019-12-13
00888867336520Arthrex®AR-1593DAR-1593D2019-12-13
00888867310209Arthrex®AR-4158TAR-4158T2019-11-15
00888867561687Arthrex®AR-2600FSF-1AR-2600FSF-12026-03-17
00888867561694Arthrex®AR-2600FSF-2AR-2600FSF-22026-03-17
00888867561700Arthrex®AR-2600FSF-3AR-2600FSF-32026-03-17
00888867463363Arthrex®AR-8974-02AR-8974-022026-03-16
00888867519459Arthrex®AR-8974FCAR-8974FC2026-03-16
00888867519473Arthrex®AR-8974FCLAR-8974FCL2026-03-16
00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
00888867519510Arthrex®AR-8974TLAR-8974TL2026-03-16
00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
00888867529052Arthrex®AR-8827H-14AR-8827H-142026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390002233SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390191135PRIMALIMACORPORATE SPAPHX2026-02-19
08033390201971PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202299PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202305PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202312PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202466PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202473PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202480PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202497PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202503PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202602PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202619PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202626PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202633PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202640PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202657PRIMALIMACORPORATE SPAPHX2026-02-19
08033390248433PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248556PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248563PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248587PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248594PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248600PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248617PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248624PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248631PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19