FDA.reportPublic FDA data

JARVIS HUMERAL TRAY N°1

Primary DI
03661489724466
Brand
JARVIS HUMERAL TRAY N°1
Company
FOURNITURES HOSPITALIERES INDUSTRIE
Model
272446-JARVIS HUMERAL TRAY N°1
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254003000JARVIS Metaphyseal StemFH Industrie2026-01-09PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661489724466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661489724466036614897244663661489724466

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33298556895n.rahimi@fhortho.com

Regulatory Flags#

DUNS number
261839898
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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
03661489723421JARVIS Diaphyseal Stem Standard272342 - JARVIS DIAPHYSEAL STEM STANDARD D8 L952025-12-16

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