Shoulder System

GUDID 07630040734042

Long humeral diaphysis - L200 - 7

Medacta International SA

Total shoulder prosthesis
Primary Device ID07630040734042
NIH Device Record Key1030f0c1-d0aa-4213-8df5-2ad191defbeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder System
Version Model Number04.01.0225
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
GS107630040734042 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-07
Device Publish Date2020-03-30

On-Brand Devices [Shoulder System]

07630040719964Glenoid Polyaxial non-locking screw – L50
07630040719957Glenoid Polyaxial non-locking screw – L46
07630040719940Glenoid Polyaxial non-locking screw – L42
07630040719933Glenoid Polyaxial non-locking screw – L38
07630040719926Glenoid Polyaxial non-locking screw – L34
07630040719919Glenoid Polyaxial non-locking screw – L30
07630040719902Glenoid Polyaxial non-locking screw – L26
07630040719896Glenoid Polyaxial non-locking screw – L22
07630040719889Glenoid Polyaxial non-locking screw – L18
07630040719872Glenoid Polyaxial non-locking screw – L14
07630040715492Threaded glenoid baseplate Ø27x30
07630040715485Threaded glenoid baseplate Ø27x25
07630040715478Threaded glenoid baseplate Ø24.5x30
07630040708135Glenoidsphere 32xØ24.5
07630040708098Threaded glenoid baseplate Ø24.5x25
07630040706636Glenoidsphere screw
07630040706629Double Eccenter / Reverse metaphysis screw
07630040706612Glenoidsphere 42x27
07630040706605Glenoidsphere 39xØ27
07630040706599Glenoidsphere 36xØ27
07630040706582Glenoidsphere 42xØ24.5
07630040706575Glenoidsphere 39xØ24.5
07630040706568Glenoidsphere 36xØ24.5
07630040706551Glenoidsphere 36xØ22
07630040706544Glenoidsphere 32xØ22
07630040706537Glenoid polyaxial locking screw - L50
07630040706520Glenoid polyaxial locking screw - L46
07630040706513Glenoid polyaxial locking screw - L42
07630040706506Glenoid polyaxial locking screw - L38
07630040706490Glenoid polyaxial locking screw - L34
07630040706483Glenoid polyaxial locking screw - L30
07630040706476Glenoid polyaxial locking screw - L26
07630040706469Glenoid polyaxial locking screw - L22
07630040706452Glenoid polyaxial locking screw - L18
07630040706445Glenoid polyaxial locking screw - L14
07630040706438Glenoid baseplate Ø27x35
07630040706421Glenoid baseplate Ø27x25
07630040706414Glenoid baseplate Ø27x15
07630040706407Glenoid baseplate Ø24.5x35
07630040706391Glenoid baseplate Ø24.5x25
07630040706384Glenoid baseplate Ø24.5x15
07630040706377Glenoid baseplate Ø22x35
07630040706360Glenoid baseplate Ø22x25
07630040706353Glenoid baseplate Ø22x15
07630040706346Humeral Reverse HC Liner Ø42/+6mm
07630040706339Humeral Reverse HC Liner Ø42/+3mm
07630040706322Humeral Reverse HC Liner Ø42/+0mm
07630040706315Humeral Reverse HC Liner Ø39/+6mm
07630040706308Humeral Reverse HC Liner Ø39/+3mm
07630040706292Humeral Reverse HC Liner Ø39/+0mm

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