Kmi Cement Restrictor Implant

FDA 510(k) K061465 · Kinetikos Medical, Inc.

Unknown

510(k) numberK061465

Submission

Device name
Kmi Cement Restrictor Implant
Applicant
Kinetikos Medical, Inc.
Carlsbad, CA, US
Received
May 26, 2006
Decision date
October 5, 2006
Decision
Unknown (SESU)
Type
Traditional 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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K210062Mectaplug PE IIJDK · Traditional Medacta International S.A.04/08/2021SE
K061698Modification to Life Spine Cement RestrictorJDK · Special Life Spine07/12/2006SE
K060247Life Spine Cement RestrictorJDK · Traditional Life Spine05/11/2006SESU
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
K050699Modification to: Vented Cement Restrictor, Model 60102-000-001/004JDK · Special Amedica Corp.04/15/2005SE

More from Amedica Corp.

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K032806Katalyst Radial Head ImplantKWI · Traditional 04/16/2004SE
K040356Kompressor Screw SystemHWC · Special 03/01/2004SE
K024233Kompressor Screw SystemHWC · Traditional 02/06/2003SE
K030037Universal Total Wrist SystemJWJ · Special 02/05/2003SE
K023770K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)KWD · Special 12/12/2002SE
K020554Modification to Universal Total Wrist SystemJWJ · Special 05/03/2002SE
K991873Kmi Wrist Fusion SystemHRS · Traditional 08/17/1999SE

Questions and answers

When was Kmi Cement Restrictor Implant cleared by the FDA?

Kmi Cement Restrictor Implant (K061465) received a 510(k) decision of Unknown on October 5, 2006, 132 days after the submission was received.

What is the product code of K061465?

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