Cleared Traditional

ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES

K090887 · SpineCraft · Orthopedic

Oct 2009

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K090887 is an FDA 510(k) clearance for the ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by SpineCraft (Round Rock, US). The FDA issued a Cleared decision on October 30, 2009, 213 days after receiving the submission on March 31, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K090887 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2009
Decision Date	October 30, 2009
Days to Decision	213 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.