Shoulder Pure Planning 20-8090-007-00

GUDID 00889024563438

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

Primary Device ID	00889024563438
NIH Device Record Key	9ccb16a6-5dd9-43e5-add0-bd03e3213d1f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Shoulder Pure Planning
Version Model Number	20-8090-007-00
Catalog Number	20-8090-007-00
Company DUNS	205670032
Company Name	Orthosoft Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com
Phone	574-371-3710
Email	personalizedsolutions@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024563438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K190595

FDA Product Code

QHE	Shoulder Arthroplasty Implantation System