← DeviceClear
HomeDevice Clearances

PFX SPINOUS PROCESS FIXATION SYSTEM — Innovasis, Inc. (510(k) K132765)

PFX SPINOUS PROCESS FIXATION SYSTEM — Innovasis, Inc. (510(k) K132765) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: PFX SPINOUS PROCESS FIXATION SYSTEM; Applicant: Innovasis, Inc.; Clearance track: 510(k).

Device namePFX SPINOUS PROCESS FIXATION SYSTEM
ApplicantInnovasis, Inc.
Clearance track510(k)
Submission numberK132765
DecisionSubstantially Equivalent
Decision date2014-07-14
Date received2013-09-04
Product codePEK
Device class2
Medical specialtyOrthopedic
Applicant locationUT, US
SourceopenFDA device

🔍 Search all device clearances →