Cleared Traditional

Tyber Medical PT Interbody Spacer System

K172185 · Tyber Medical, LLC · Orthopedic

Dec 2017

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K172185 is an FDA 510(k) clearance for the Tyber Medical PT Interbody Spacer System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on December 21, 2017, 154 days after receiving the submission on July 20, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K172185 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 2017
Decision Date	December 21, 2017
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.