PLS (Posterior Lumbar System)

FDA 510(k) K140787 · Sintea Plustek, LLC

Substantially Equivalent

510(k) numberK140787

Submission

Device name
PLS (Posterior Lumbar System)
Applicant
Sintea Plustek, LLC
Fr. Myers, FL, US
Received
March 31, 2014
Decision date
May 30, 2014
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

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K161151Spinal fixation systemMNH · Traditional Canwell Medical Co., Ltd.09/21/2016SE
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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

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Questions and answers

When was PLS (Posterior Lumbar System) cleared by the FDA?

PLS (Posterior Lumbar System) (K140787) received a 510(k) decision of Substantially Equivalent on May 30, 2014, 60 days after the submission was received.

What is the product code of K140787?

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