Class Class II

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (K251073)

K251073 2025-07-23 Traditional
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Description

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) by Innovasis, Inc., an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251073
Clearance Date2025-07-23
Clearance TypeTraditional
Product CodeOLO
Regulation Number882.4560

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Predicate lineage for K251073

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (K251073) cites 4 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K250182Innovasis Navigation InstrumentsInnovasis, Inc.2025
K241276Vector™ Pedicle Screw SystemInnovasis, Inc.2024
K171651EXCELSIUS GPSGlobus Medical, Inc.2017
K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00Innovasis, Inc.2010

Trace the full predicate network for K251073

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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