Equinoxe 300-60-01

GUDID 10885862559272

Exactech, Inc.

Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis Coated shoulder humeral stem prosthesis
Primary Device ID10885862559272
NIH Device Record Keyc76e5c4a-e8d4-4f58-9c77-0d9a97546b46
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquinoxe
Version Model Number300-60-01
Catalog Number300-60-01
Company DUNS157565946
Company NameExactech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]
GS110885862559272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [Equinoxe]


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