QUANTUM® Patient Specific Instrumentation (PSI) System

Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

In2Bones SAS

The following data is part of a premarket notification filed by In2bones Sas with the FDA for Quantum® Patient Specific Instrumentation (psi) System.

Pre-market Notification Details

Device IDK211883
510k NumberK211883
Device Name:QUANTUM® Patient Specific Instrumentation (PSI) System
ClassificationProsthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Applicant In2Bones SAS 26 Chemin Du Petit Bois Ecully,  FR 69130
ContactMorgane Grenier
CorrespondentChristine Scifert
In2Bones USA 6600 Poplar Ave, Suite 115 Memphis,  TN  38119
Product CodeHSN  
CFR Regulation Number888.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-08-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03701337614355 K211883 000

Trademark Results [QUANTUM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTUM
QUANTUM
98867628 not registered Live/Pending
Xplorian LLC
2024-11-22
QUANTUM
QUANTUM
98807712 not registered Live/Pending
Into-Me-Sea LLC
2024-10-17
QUANTUM
QUANTUM
98804816 not registered Live/Pending
QuantumADR LLC
2024-10-16
QUANTUM
QUANTUM
98719255 not registered Live/Pending
Evolve Biologix Inc.
2024-08-27
QUANTUM
QUANTUM
98705080 not registered Live/Pending
Intervet Inc.
2024-08-19
QUANTUM
QUANTUM
98650676 not registered Live/Pending
Raynor Marketing Ltd.
2024-07-16
QUANTUM
QUANTUM
98424129 not registered Live/Pending
HOUSE X AMERICA LLC
2024-02-27
QUANTUM
QUANTUM
98417725 not registered Live/Pending
Meta Materials Inc.
2024-02-23
QUANTUM
QUANTUM
98388177 not registered Live/Pending
Thomas P. Dakich
2024-02-02
QUANTUM
QUANTUM
98386723 not registered Live/Pending
Kuku, Jalil
2024-02-01
QUANTUM
QUANTUM
98384415 not registered Live/Pending
Starkey Laboratories, Inc.
2024-01-31
QUANTUM
QUANTUM
98362353 not registered Live/Pending
The Upper Deck Company
2024-01-17

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