FDA.report

Humeral Cup Stability

Primary DI
03701037310502
Brand
Humeral Cup Stability
Company
FX SOLUTIONS
Model
314-0906
Catalog number
314-0906
Device description
HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +6
Published
2020-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03701037310502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03701037310502037010373105023701037310502

GMDN Terms

TermDefinition
Polyethylene reverse shoulder prosthesis cupA sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.

Sterilization Methods

Method

Regulatory Flags

DUNS number
263076196
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 DIBrandModelCatalogPublished
03701037311776Humelock II926-10412025-08-01
03701037311783Humelock II926-10422025-08-01
03701037311790Humelock II926-10432025-08-01
03701037311806Humelock II926-10442025-08-01
03701037311813Humelock II926-10452025-08-01
03701037316450FX V135951-89032025-08-01
03701037321133Humelock Reversed961-00032025-08-01
03701037321140Humelock Reversed Shoulder906-00502025-08-01
03701037319512Full wedge baseplates951-01072025-06-13
03701037318669FX V135 Shoulder Prosthesis951-52102025-04-09
03701037318676FX V135 Shoulder Prosthesis951-52122025-04-09
03701037318683FX V135 Shoulder Prosthesis951-54102025-04-09
03701037318690FX V135 Shoulder Prosthesis951-54122025-04-09
03701037318706FX V135 Shoulder Prosthesis951-54142025-04-09
03701037318713FX V135 Shoulder Prosthesis951-56122025-04-09
03701037318737FX V135 Shoulder Prosthesis951-56162025-04-09
03701037318652FX V135 Shoulder Prosthesis951-52082025-04-07
03701037320426EasyTech Anatomical910-0130-CM12025-03-03
03701037320532Humelock II603-00172025-03-03
03701037321010FX V135911-2051911-20512025-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885862648099EquinoxeExactech, Inc.HSD2026-03-19
10885862648105EquinoxeExactech, Inc.HSD2026-03-19
10885862648129EquinoxeExactech, Inc.HSD2026-03-19
10885862648136EquinoxeExactech, Inc.HSD2026-03-19
10885862648167EquinoxeExactech, Inc.HSD2026-03-19
10885862648174EquinoxeExactech, Inc.HSD2026-03-19
10885862648259EquinoxeExactech, Inc.HSD2026-03-19
10885862648266EquinoxeExactech, Inc.HSD2026-03-19
10885862648273EquinoxeExactech, Inc.HSD2026-03-19
10885862648280EquinoxeExactech, Inc.HSD2026-03-19
10885862648297EquinoxeExactech, Inc.HSD2026-03-19
10885862648303EquinoxeExactech, Inc.HSD2026-03-19
10885862662446EquinoxeExactech, Inc.HSD2026-03-19
10885862662453EquinoxeExactech, Inc.HSD2026-03-19
10885862662460EquinoxeExactech, Inc.HSD2026-03-19
10885862662477EquinoxeExactech, Inc.HSD2026-03-19
10885862662484EquinoxeExactech, Inc.HSD2026-03-19
10885862662491EquinoxeExactech, Inc.HSD2026-03-19
10885862665782EquinoxeExactech, Inc.HSD2026-03-19
03661489523618JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723421JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723438JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723445JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723452JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723469JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723476JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723483JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723490JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723506JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723537JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16