FDA.report

510(k) K232044

Device
Invictus Robotic Navigation Instruments
Applicant
Alphatec Spine, Inc.
510(k) number
K232044
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-06
Date received
2023-07-10
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
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
Unnati Bhuptani
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376536101InvictusALPHATEC SPINE, INC.2024-03-10

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K260546Q Pedicle InstrumentsK2m, Inc.2026-03-17
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K260222Mako Total Knee ApplicationMako Surgical Corp.2026-02-25
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K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc.2026-02-19
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K254148VERTICALE GPS InstrumentsSilony Medical GmbH2026-02-19