MyPAO Planning report

GUDID 07630971243378

MyPAO Planning report

Medacta International SA

Orthopaedic/craniofacial implantation planning software
Primary Device ID07630971243378
NIH Device Record Key65c7d536-cbab-4cce-bbc3-7556c33722ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyPAO Planning report
Version Model Number05.07.001SWO
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630971243378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-02
Device Publish Date2021-02-22

Devices Manufactured by Medacta International SA

07630345798022 - Hip Instruments2025-01-28 Bayonet drill bit Ø3.2mm L15 - Single use
07630345798039 - Hip Instruments2025-01-28 Bayonet drill bit Ø3.2mm L20 - Single use
07630345798213 - Hip Instruments2025-01-28 Bayonet drill bit Ø3.6mm L35 - Single use
07630345798220 - Hip Instruments2025-01-28 Bayonet drill bit Ø3.6mm L40 - Single use
07630345798237 - Hip Instruments2025-01-28 Bayonet drill bit Ø3.6mm L45 - Single use
07630345798244 - Hip Instruments2025-01-28 Bayonet drill bit Ø3.6mm L50 - Single use
07630345798251 - Hip Instruments2025-01-28 Bayonet drill bit Ø3.6mm L55 - Single use
07630345702425 - Knee Instruments2025-01-21 Trial insert size 1R - 7mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.