FDA.report

510(k) K230313

Device
QUANTUM Patient Specific Instrumentation (PSI) System
Applicant
In2bones Sas
510(k) number
K230313
Product code
HSN
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-06
Date received
2023-02-06
Regulation
888.3110
Classification name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sabina Ahaddad
Address
26 Chemin Du Petit Bois Ecully FR 69130 69130

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemIn2bones Sas2024-04-23
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K232002Vantage® Total Ankle SystemExactech, Inc.2023-09-11
K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC2023-07-17
K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2023-01-27