FDA.reportPublic FDA data

510(k) K241276

Device
Vector? Pedicle Screw System
Applicant
Innovasis, Inc.
510(k) number
K241276
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-20
Date received
2024-05-06
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michael Thomas
Address
614 E 3900 S Salt Lake City UT US 84107 84107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-07-01
K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.2026-06-17
K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.2026-06-09