FDA.reportPublic FDA data

ARROW®

Primary DI
03661489673610
Brand
ARROW®
Company
FOURNITURES HOSPITALIERES INDUSTRIE
Model
267361 - HUMERAL STEM, Ø16 L140
Published
2015-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150568000ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie2015-10-29PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661489673610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661489673610036614896736103661489673610

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Regulatory Flags#

DUNS number
261839898
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661489724442JARVIS GUIDE DE COUPE EXTRA-MODULAIRE272444-JARVIS GUIDE DE COUPE EXTRA-MODULAIRE2026-05-08
03661489724459JARVIS COMPACTEUR INITIAL AMOVIBLE272445-JARVIS COMPACTEUR INITIAL AMOVIBLE2026-05-08
03661489724466JARVIS HUMERAL TRAY N°1272446-JARVIS HUMERAL TRAY N°12026-05-08
03661489724473JARVIS HUMERAL TRAY N°2272447-JARVIS HUMERAL TRAY N°22026-05-08
03661489724480JARVIS HUMERAL INSERT BOX272448-JARVIS HUMERAL INSERT BOX2026-05-08
03661489708275ARROW Reverse Porous Glenoid270827 - ARROW SCREWDRIVER D3.52026-02-18
03661489718175ARROW Short Stem Humeral System271817 - ARROW BROCHE D3 L3502026-02-18
03661489723629JARVIS METAPHYSEAL STEM272362 - JARVIS METAPHYSEAL STEM V2 T12026-01-15
03661489723636JARVIS METAPHYSEAL STEM272363 - JARVIS METAPHYSEAL STEM V2 T22026-01-15
03661489723643JARVIS METAPHYSEAL STEM272364 - JARVIS METAPHYSEAL STEM V2 T32026-01-15
03661489723650JARVIS METAPHYSEAL STEM272365 - JARVIS METAPHYSEAL STEM V2 T42026-01-15
03661489723667JARVIS METAPHYSEAL STEM272366 - JARVIS METAPHYSEAL STEM V2 T52026-01-15
03661489723674JARVIS METAPHYSEAL STEM272367 - JARVIS METAPHYSEAL STEM V2 T62026-01-15
03661489724213JARVIS METAPHYSEAL STEM272421 - JARVIS MODULAR BROACH T12026-01-15
03661489724220JARVIS METAPHYSEAL STEM272422 - JARVIS MODULAR BROACH T22026-01-15
03661489724237JARVIS METAPHYSEAL STEM272423 - JARVIS MODULAR BROACH T32026-01-15
03661489724244JARVIS METAPHYSEAL STEM272424 - JARVIS MODULAR BROACH T42026-01-15
03661489724251JARVIS METAPHYSEAL STEM272425 - JARVIS MODULAR BROACH T52026-01-15
03661489724268JARVIS METAPHYSEAL STEM272426 - JARVIS MODULAR BROACH T62026-01-15
03661489523618JARVIS Diaphyseal Stem Standard272361 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D162025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031961CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031978CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031985CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17