Modification to Fortitude Cement Restrictor
FDA 510(k) K031837 · Spinal Concepts, Inc.
510(k) numberK031837
Submission
- Device name
- Modification to Fortitude Cement Restrictor
- Applicant
- Spinal Concepts, Inc.
Austin, TX, US - Received
- June 16, 2003
- Decision date
- July 24, 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
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 |
|---|---|---|
| K051000 | Fortitude Vue Vertebral Body Replacement DeviceMQP · Special | 05/19/2005SE |
| K050706 | Harmony Port System, Model 1907 SeriesGZT · Traditional | 04/15/2005SE |
| K040096 | Spinal Concepts, Inc. Tandem Spinous Process Plate SystemKWP · Traditional | 07/01/2004SE |
| K033663 | Spinal Concepts Inc. CodaMQP · Traditional | 05/27/2004SE |
| K033517 | Spinal Concepts Inc. Cadence and TraxisMQP · Special | 02/18/2004SE |
| K031855 | Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional | 09/17/2003SE |
| K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional | 09/11/2003SE |
| K031318 | Traxis Cement RestrictorJDK · Special | 08/22/2003SESU |
| K031672 | Spinal Concepts, Inc. Infix SystemMQP · Traditional | 08/07/2003SE |
| K030087 | Spinal Concepts, Inc. Bacfix Ti Spinal SystemNKB · Abbreviated | 07/17/2003SE |
Questions and answers
When was Modification to Fortitude Cement Restrictor cleared by the FDA?
Modification to Fortitude Cement Restrictor (K031837) received a 510(k) decision of Substantially Equivalent on July 24, 2003, 38 days after the submission was received.
What is the product code of K031837?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.