Interpore Cross Cement Restrictor
FDA 510(k) K032095 · Interpore Cross Intl.
510(k) numberK032095
Submission
- Device name
- Interpore Cross Cement Restrictor
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- July 8, 2003
- Decision date
- August 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K210062 | Mectaplug PE IIJDK · Traditional | Medacta International S.A. | 04/08/2021SE |
| K061465 | Kmi Cement Restrictor ImplantJDK · Traditional | Kinetikos Medical, Inc. | 10/05/2006SESU |
| K061698 | Modification to Life Spine Cement RestrictorJDK · Special | Life Spine | 07/12/2006SE |
| K060247 | Life Spine Cement RestrictorJDK · Traditional | Life Spine | 05/11/2006SESU |
| K060132 | Spinal USA Cement Restrictor SystemJDK · Traditional | Spinal USA | 03/16/2006SE |
| K051371 | Interbody Innovations Cement RestrictorJDK · Traditional | Interbody Innovations, Llp | 12/06/2005SESU |
| K051836 | Skelite Resorbable Cement RestrictorJDK · Traditional | Millenium Biologix, Inc. | 11/21/2005SESU |
| K051607 | Novaspine Cement Restrictor NSCRJDK · Traditional | Novaspine, LLC | 10/07/2005SE |
| K052367 | Scient'X Cement RestrictorJDK · Traditional | Scient'X | 10/05/2005SESU |
| K041382 | Polygraft BGS; Bone Graft SubstituteJDK · Traditional | Osteobiologics, Inc. | 06/17/2005SESU |
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| K040928 | Expandable PEEK VBR ImplantMQP · Traditional | 08/27/2004SE |
| K041794 | C-Tek C-Thru Anterior Cervical Plate SystemKWQ · Special | 07/19/2004SE |
| K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatKWP · Special | 07/01/2004SE |
| K033961 | Altius Oct SystemKWP · Special | 04/14/2004SE |
| K040168 | Modification to Geo StructureMQP · Special | 04/08/2004SE |
Questions and answers
When was Interpore Cross Cement Restrictor cleared by the FDA?
Interpore Cross Cement Restrictor (K032095) received a 510(k) decision of Substantially Equivalent on August 8, 2003, 31 days after the submission was received.
What is the product code of K032095?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.