FDA.reportPublic FDA data

ARROW®

Primary DI
03661489651069
Brand
ARROW®
Company
FOURNITURES HOSPITALIERES INDUSTRIE
Model
265106 - HUMERAL STEM, Ø14 L135
Published
2015-10-24
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
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093599000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093599000ARROW ANATOMICAL SHOULDER SYSTEMFournitures Hospitalieres Industrie2010-11-24KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661489651069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661489651069036614896510693661489651069

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.

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
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.HSD2026-05-28
07613327354331REUNIONStryker GmbHKWS2022-11-15
07613327354355REUNIONStryker GmbHKWS2022-11-15
07613327354379REUNIONStryker GmbHHSD2022-11-15
07613327354386REUNIONStryker GmbHHSD2022-11-15
07613327354799REUNIONStryker GmbHHSD2022-11-15
07613327354805REUNIONStryker GmbHKWS2022-11-15
07613327354843REUNIONStryker GmbHHSD2022-11-15
07613327354850REUNIONStryker GmbHHSD2022-11-15
07613327354867REUNIONStryker GmbHHSD2022-11-15
07613327354874REUNIONStryker GmbHHSD2022-11-15
07613327354898REUNIONStryker GmbHHSD2022-11-15
07613327354904REUNIONStryker GmbHKWS2022-11-15
07613327354935REUNIONStryker GmbHKWS2022-11-15
07613327354942REUNIONStryker GmbHKWS2022-11-15
07613327354980REUNIONStryker GmbHHSD2022-11-15
07613327355024REUNIONStryker GmbHKWS2022-11-15
07613327355079REUNIONStryker GmbHHSD2022-11-15
07613327355093REUNIONStryker GmbHKWS2022-11-15
07613327355109REUNIONStryker GmbHKWS2022-11-15
07613327355116REUNIONStryker GmbHHSD2022-11-15
07613327355123REUNIONStryker GmbHHSD2022-11-15
07613327355147REUNIONStryker GmbHHSD2022-11-15
07613327355161REUNIONStryker GmbHHSD2022-11-15
07613327355192REUNIONStryker GmbHHSD2022-11-15
07613327355215REUNIONStryker GmbHHSD2022-11-15
07613327355222REUNIONStryker GmbHKWS2022-11-15
07613327355239REUNIONStryker GmbHHSD2022-11-15