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

07630542779411 - Hip Instruments2025-07-24 Straight 35° broach adapter
07630542779428 - Hip Instruments2025-07-24 Straight 0° broach adapter
07630542779435 - Hip Instruments2025-07-24 Cup impaction adapter - Straight
07630542779442 - Hip Instruments2025-07-24 Modular anvil - Long
07630542779459 - Hip Instruments2025-07-24 Liner impaction adapter
07630542779466 - Hip Instruments2025-07-24 Head impaction adapter
07630542779473 - Hip Instruments2025-07-24 Stem impaction adapter - Mfinity
07630542782459 - Hip Instruments2025-07-24 Hip modular adapters tray

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