Lancer Pedicle Screw System

FDA 510(k) K110633 · Spinal Solutions, LLC

Substantially Equivalent

510(k) numberK110633

Submission

Device name
Lancer Pedicle Screw System
Applicant
Spinal Solutions, LLC
Round Rock, TX, US
Received
March 4, 2011
Decision date
December 15, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code MNH

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K162066Reliance Spinal Screw SystemMNH · Traditional Reliance Medical Systems, LLC12/02/2016SE
K162801CastleLoc Spinal Fixation SystemMNH · Special L&K BIOMED Co., Ltd.11/03/2016SE
K162143FixxSure® X-LinkMNH · Traditional Innovasis, Inc.09/23/2016SE
K161151Spinal fixation systemMNH · Traditional Canwell Medical Co., Ltd.09/21/2016SE
K162189ANAX™ 5.5 Spinal SystemMNH · Special U&I Corporation08/30/2016SE
K151362HC Spinal SystemMNH · Traditional Hung Chun Bio-S Co., Ltd.05/05/2016SE
K153404Zavation Spinal SystemMNH · Traditional Zavation, LLC04/21/2016SE
K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special Captiva Spine03/02/2016SE
K143013Spinal Inner Fixation SystemMNH · Traditional Changzhou Dingjian Medical Appliance Co., Ltd.12/11/2015SE
K151695Romeo posterior osteosynthesis systemMNH · Traditional Spineart09/10/2015SE

Questions and answers

When was Lancer Pedicle Screw System cleared by the FDA?

Lancer Pedicle Screw System (K110633) received a 510(k) decision of Substantially Equivalent on December 15, 2011, 286 days after the submission was received.

What is the product code of K110633?

The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.