Scient'X Cement Restrictor
FDA 510(k) K052367 · Scient'X
510(k) numberK052367
Submission
- Device name
- Scient'X Cement Restrictor
- Applicant
- Scient'X
Round Rock, TX, US - Received
- August 29, 2005
- Decision date
- October 5, 2005
- Decision
- Unknown (SESU)
- 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 |
| 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 |
More from Amedica Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K071261 | Isobar Semi-Rigid Dual DampenerNQP · Traditional | 04/17/2008SE |
| K062912 | Scient'X Spinal SystemMNI · Special | 02/05/2007SE |
| K052763 | Stella Cervical PlateKWQ · Special | 11/10/2005SE |
| K050348 | Co Vertebral Body ReplacementMQP · Special | 05/27/2005SE |
| K051063 | Polyaxial Hemispherical Spinal ScrewsMNI · Special | 05/23/2005SE |
| K043001 | MX Polyaxial Pedicle ScrewMNH · Special | 12/01/2004SE |
| K042964 | MX Monoaxial Pedicle ScrewMNH · Special | 11/22/2004SE |
| K042317 | Cervical PlateKWQ · Special | 09/24/2004SE |
| K040747 | Aladyn Rigid Spine PlateMNH · Special | 06/17/2004SE |
| K040454 | Biofill Bone Void FillerMQV · Traditional | 05/07/2004SE |
Questions and answers
When was Scient'X Cement Restrictor cleared by the FDA?
Scient'X Cement Restrictor (K052367) received a 510(k) decision of Unknown on October 5, 2005, 37 days after the submission was received.
What is the product code of K052367?
The FDA product code is JDK – Prosthesis, Hip, Cement Restrictor, a Class II (moderate risk) device regulated under 21 CFR 878.3300.