Cleared Traditional

Tyber Medical PT Interbody Spacer

K182284 · Tyber Medical, LLC · Orthopedic

Jan 2019

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K182284 is an FDA 510(k) clearance for the Tyber Medical PT Interbody Spacer, 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 January 18, 2019, 148 days after receiving the submission on August 23, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K182284 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2018
Decision Date	January 18, 2019
Days to Decision	148 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.