FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867296602
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9503-3633-6
Catalog number
AR-9503-3633-6
Device description
36 +6 / 33 Combo Humeral Insert
Published
2018-08-20
Public version status
Update
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
00888867296602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867296602008888672966028888672966020888867296602

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
+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

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Primary DI, Brand, Company table
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08033390191135PRIMALIMACORPORATE SPAPHX2026-02-19
08033390201971PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202299PRIMALIMACORPORATE SPAPHX2026-02-19
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08033390202466PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202473PRIMALIMACORPORATE SPAPHX2026-02-19
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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