FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867229518
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-9548-19RCA
Catalog number
AR-9548-19RCA
Device description
Revers CA Humeral Head, 48/19
Published
2017-02-15
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867229518PrimaryGS10
M150AR954819RCA1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867229518008888672295188888672295180888867229518

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.

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
00888867543904Arthrex®AR-1101TH-13CT-SAR-1101TH-13CT-S2026-09-25
00888867543911Arthrex®AR-1101TH-8CT-SAR-1101TH-8CT-S2026-09-25
00888867543928Arthrex®AR-1101TH-13OT-SAR-1101TH-13OT-S2026-09-25
00888867543935Arthrex®AR-1101TH-8OT-SAR-1101TH-8OT-S2026-09-25
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867291690Arthrex®AR-3350-4031AR-3350-40312018-12-13
00888867291751Arthrex®AR-3355-4031AR-3355-40312018-12-13
00888867161085Arthrex®AR-3350-4071AR-3350-40712018-12-13
00888867161207Arthrex®AR-3355-4071AR-3355-40712018-12-13
00888867504059Arthrex®AR-9650CAR-9650C2026-09-21
00888867504066Arthrex®AR-9650C-01AR-9650C-012026-09-21
00888867504073Arthrex®AR-9650C-02AR-9650C-022026-09-21
00888867570764Arthrex®AR-9650SFL-10256AR-9650SFL-102562026-09-21
00888867570771Arthrex®AR-9650SFL-11250AR-9650SFL-112502026-09-21
00888867550292Arthrex®AR-6533S-STAR-6533S-ST2026-09-18
00888867550308Arthrex®AR-6533S-XLAR-6533S-XL2026-09-18
00888867550315Arthrex®AR-6534S-STAR-6534S-ST2026-09-18
00888867550322Arthrex®AR-6534S-XLAR-6534S-XL2026-09-18
00888867550339Arthrex®AR-6533S-STSAR-6533S-STS2026-09-18
00888867550346Arthrex®AR-6533S-XLSAR-6533S-XLS2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2026-08-03
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14