Cleared Traditional

C-PLUS

K133623 · Pioneer Surgical Technology, Inc. · Orthopedic

Feb 2014

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K133623 is an FDA 510(k) clearance for the C-PLUS, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on February 10, 2014, 76 days after receiving the submission on November 26, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K133623 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2013
Decision Date	February 10, 2014
Days to Decision	76 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.