510(k) Report

Devices descending from K092467

10 later devices reach Vectorvision Cranial, Vectorvision Ent, Kolibri Cranial, Kolibri Ent, Cranial… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231897NeuroAlign softwareMedivis, Inc.20250—
+1K201752Disposable Pre-calibrated SuctionBrainlab AG20210—
+1K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software…Brainlab AG20203—
+1K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+2K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+2K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial…Brainlab AG20230—
+2K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+2K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+3K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+3K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201