RPX Titanium Cemnt Restrictor
FDA 510(k) K020344 · Sulzer Spine-Tech
510(k) numberK020344
Submission
- Device name
- RPX Titanium Cemnt Restrictor
- Applicant
- Sulzer Spine-Tech
Minneapolis, MN, US - Received
- February 1, 2002
- Decision date
- May 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code JDK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Osteobiologics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K022374 | Cadence Spinal Fixation SystemKWP · Special | 09/24/2002SE |
| K020196 | Modification to Silhouette Spinal Fixation SystemMNH · Special | 02/15/2002SE |
| K012173 | Device Modification of Silhouette Spindal Fixation SystemKWP · Special | 09/28/2001SE |
| K012305 | Modification to: Trinica Anterior Cervical Plate SystemKWQ · Special | 08/22/2001SE |
| K993067 | Silhouette Spinal Fixation SystemKWP · Special | 11/16/1999SE |
| K992276 | Modification to Silhouette Spinal Fixation SystemMNI · Traditional | 10/01/1999SE |
Questions and answers
When was RPX Titanium Cemnt Restrictor cleared by the FDA?
RPX Titanium Cemnt Restrictor (K020344) received a 510(k) decision of Substantially Equivalent on May 2, 2002, 90 days after the submission was received.
What is the product code of K020344?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.