PEEK Cement Restrictor X-Box

FDA 510(k) K041583 · Innovasis, Inc.

Unknown

510(k) numberK041583

Submission

Device name
PEEK Cement Restrictor X-Box
Applicant
Innovasis, Inc.
Salt Lake City, UT, US
Received
June 11, 2004
Decision date
July 22, 2004
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

Other 510(k)s with product code JDK

510(k)DeviceApplicantDecision
K210062Mectaplug PE IIJDK · Traditional Medacta International S.A.04/08/2021SE
K061465Kmi Cement Restrictor ImplantJDK · Traditional Kinetikos Medical, Inc.10/05/2006SESU
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

More from Osteobiologics, Inc.

510(k)DeviceDecision
K250076Endeavor™ Stand-Alone Cervical IBF SystemOVE · Traditional 09/25/2025SE
K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…OLO · Traditional 07/23/2025SE
K250603AxTiHA® Stand-Alone ALIF SystemOVD · Special 03/24/2025SE
K250182Innovasis Navigation InstrumentsOLO · Traditional 03/24/2025SE
K241276Vector™ Pedicle Screw SystemNKB · Traditional 05/20/2024SE
K231899HAtetracell™-C Titanium Cervical IBF SystemODP · Traditional 10/17/2023SE
K223511Excella Navigation InstrumentsOLO · Traditional 05/02/2023SE
K223510Matrix HA Fusion Porous Cervical IBF SystemODP · Special 12/12/2022SE
K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemODP · Traditional 08/26/2022SE
K212967AxTiHA Stand-Alone ALIF SystemOVD · Special 10/15/2021SE

Questions and answers

When was PEEK Cement Restrictor X-Box cleared by the FDA?

PEEK Cement Restrictor X-Box (K041583) received a 510(k) decision of Unknown on July 22, 2004, 41 days after the submission was received.

What is the product code of K041583?

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