Spinal USA Cement Restrictor System
FDA 510(k) K060132 · Spinal USA
510(k) numberK060132
Submission
- Device name
- Spinal USA Cement Restrictor System
- Applicant
- Spinal USA
Brandon, MS, US - Received
- January 18, 2006
- Decision date
- March 16, 2006
- 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 |
| 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 |
| K050699 | Modification to: Vented Cement Restrictor, Model 60102-000-001/004JDK · Special | Amedica Corp. | 04/15/2005SE |
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Questions and answers
When was Spinal USA Cement Restrictor System cleared by the FDA?
Spinal USA Cement Restrictor System (K060132) received a 510(k) decision of Substantially Equivalent on March 16, 2006, 57 days after the submission was received.
What is the product code of K060132?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.