Anatomic Shoulder Prosthesis

GUDID 07630040713078

Humeral Anatomical Metaphysis – Cemented, Size 8, 142°

Medacta International SA

Total shoulder prosthesis
Primary Device ID07630040713078
NIH Device Record Keyd150938e-9da6-4b85-ab64-7883a1a9640c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatomic Shoulder Prosthesis
Version Model Number04.01.0080
Company DUNS488227125
Company NameMedacta International SA
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630040713078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-24

On-Brand Devices [Anatomic Shoulder Prosthesis]

07630040713337Humeral Stem Screw
07630040713320Highcross PE Pegged Glenoid, Size Ø 58 mm
07630040713313Highcross PE Pegged Glenoid, Size Ø 56 mm
07630040713306Highcross PE Pegged Glenoid, Size Ø 54 mm
07630040713290Highcross PE Pegged Glenoid, Size Ø 52 mm
07630040713283Highcross PE Pegged Glenoid, Size Ø 450 mm
07630040713276Highcross PE Pegged Glenoid, Size Ø 48 mm
07630040713269Highcross PE Pegged Glenoid, Size Ø 46 mm
07630040713252Highcross PE Pegged Glenoid, Size Ø 44 mm
07630040713245Highcross PE Pegged Glenoid, Size Ø 42 mm
07630040713238Highcross PE Pegged Glenoid, Size Ø 40 mm
07630040713221Cobalt-Chromium Humeral Head, Size Ø 58 mm
07630040713214Cobalt-Chromium Humeral Head, Size Ø 56 mm
07630040713207Cobalt-Chromium Humeral Head, Size Ø 54 mm
07630040713191Cobalt-Chromium Humeral Head, Size Ø 52 mm
07630040713184Cobalt-Chromium Humeral Head, Size Ø 50 mm
07630040713177Cobalt-Chromium Humeral Head, Size Ø 48 mm
07630040713160Cobalt-Chromium Humeral Head, Size Ø 46 mm
07630040713153Cobalt-Chromium Humeral Head, Size Ø 44 mm
07630040713146Cobalt-Chromium Humeral Head, Size Ø 42 mm
07630040713139Cobalt-Chromium Humeral Head, Size Ø 40 mm
07630040713122Double Eccenter
07630040713115Humeral Anatomical Metaphysis – Cemented, Size 16, 142°
07630040713108Humeral Anatomical Metaphysis – Cemented, Size 14, 142°
07630040713092Humeral Anatomical Metaphysis – Cemented, Size 12, 142°
07630040713085Humeral Anatomical Metaphysis – Cemented, Size 10, 142°
07630040713078Humeral Anatomical Metaphysis – Cemented, Size 8, 142°
07630040713061Humeral Anatomical Metaphysis – Cemented, Size 6, 142°
07630040713054Humeral Anatomical Metaphysis – Cemented, Size 16, 128°
07630040713047Humeral Anatomical Metaphysis – Cemented, Size 14, 128°
07630040713030Humeral Anatomical Metaphysis – Cemented, Size 12, 128°
07630040713023Humeral Anatomical Metaphysis – Cemented, Size 10, 128°
07630040713016Humeral Anatomical Metaphysis – Cemented, Size 8, 128°
07630040713009Humeral Anatomical Metaphysis – Cemented, Size 6, 128°
07630040712996Humeral Anatomical Metaphysis – Cemented, Size 16, 135°
07630040712989Humeral Anatomical Metaphysis – Cemented, Size 14, 135°
07630040712972Humeral Anatomical Metaphysis – Cemented, Size 12, 135°
07630040712965Humeral Anatomical Metaphysis – Cemented, Size 10, 135°
07630040712958Humeral Anatomical Metaphysis – Cemented, Size 8, 135°
07630040712941Humeral Anatomical Metaphysis – Cemented, Size 6, 135°
07630040712934Humeral Anatomical Metaphysis – Cementless, Size 16, 142°
07630040712927Humeral Anatomical Metaphysis – Cementless, Size 15, 142°
07630040712910Humeral Anatomical Metaphysis – Cementless, Size 14, 142°
07630040712903Humeral Anatomical Metaphysis – Cementless, Size 13, 142°
07630040712897Humeral Anatomical Metaphysis – Cementless, Size 12, 142°
07630040712880Humeral Anatomical Metaphysis – Cementless, Size 11, 142°
07630040712873Humeral Anatomical Metaphysis – Cementless, Size 10, 142°
07630040712866Humeral Anatomical Metaphysis – Cementless, Size 9, 142°
07630040712859Humeral Anatomical Metaphysis – Cementless, Size 8, 142°
07630040712842Humeral Anatomical Metaphysis – Cementless, Size 7, 142°

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