Cleared Special

K220810 - Infinity? OCT System and PASS OCT Spinal System
(FDA 510(k) Clearance)

K220810 · Medicrea International · Orthopedic

Apr 2022

Decision

29d

Days

Class 2

Risk

K220810 is an FDA 510(k) clearance for the Infinity? OCT System and PASS OCT Spinal System, a Posterior Cervical Screw System (Class II — Special Controls, product code NKG), submitted by Medicrea International (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on April 19, 2022, 29 days after receiving the submission on March 21, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3075.

Submission Details

510(k) Number	K220810 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2022
Decision Date	April 19, 2022
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKG — Posterior Cervical Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3075
Definition	Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of Fusion.