Traxis Cement Restrictor

FDA 510(k) K031318 · Spinal Concepts, Inc.

Unknown

510(k) numberK031318

Submission

Device name
Traxis Cement Restrictor
Applicant
Spinal Concepts, Inc.
Austin, TX, US
Received
April 25, 2003
Decision date
August 22, 2003
Decision
Unknown (SESU)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDK – Prosthesis, Hip, Cement Restrictor
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

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K060132Spinal USA Cement Restrictor SystemJDK · Traditional Spinal USA03/16/2006SE
K051371Interbody Innovations Cement RestrictorJDK · Traditional Interbody Innovations, Llp12/06/2005SESU
K051836Skelite Resorbable Cement RestrictorJDK · Traditional Millenium Biologix, Inc.11/21/2005SESU
K051607Novaspine Cement Restrictor NSCRJDK · Traditional Novaspine, LLC10/07/2005SE
K052367Scient'X Cement RestrictorJDK · Traditional Scient'X10/05/2005SESU
K041382Polygraft BGS; Bone Graft SubstituteJDK · Traditional Osteobiologics, Inc.06/17/2005SESU

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K040096Spinal Concepts, Inc. Tandem Spinous Process Plate SystemKWP · Traditional 07/01/2004SE
K033663Spinal Concepts Inc. CodaMQP · Traditional 05/27/2004SE
K033517Spinal Concepts Inc. Cadence and TraxisMQP · Special 02/18/2004SE
K031855Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional 09/17/2003SE
K031985Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional 09/11/2003SE
K031672Spinal Concepts, Inc. Infix SystemMQP · Traditional 08/07/2003SE
K031837Modification to Fortitude Cement RestrictorJDK · Special 07/24/2003SE
K030087Spinal Concepts, Inc. Bacfix Ti Spinal SystemNKB · Abbreviated 07/17/2003SE

Questions and answers

When was Traxis Cement Restrictor cleared by the FDA?

Traxis Cement Restrictor (K031318) received a 510(k) decision of Unknown on August 22, 2003, 119 days after the submission was received.

What is the product code of K031318?

The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.