Fixcet Spinal Facet Screw System
FDA 510(k) K100154 · X-Spine Systems, Inc.
510(k) numberK100154
Submission
- Device name
- Fixcet Spinal Facet Screw System
- Applicant
- X-Spine Systems, Inc.
Miamisburg, OH, US - Received
- January 20, 2010
- Decision date
- May 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
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| K171075 | Calix-C Cervical Interbody SpacerODP · Traditional | 08/01/2017SE |
| K170224 | Spider Cervical Plating SystemKWQ · Traditional | 07/06/2017SE |
| K170530 | Butrex Lumbar Buttress Plating SystemKWQ · Special | 03/22/2017SE |
| K160959 | Xsert Lumbar Expandable Interbody SystemMAX · Traditional | 11/17/2016SE |
| K162944 | Irix-C Cervical Integrated Fusion SystemOVE · Traditional | 11/07/2016SE |
| K160428 | Certex Spinal Fixation SystemNKG · Traditional | 05/05/2016SE |
Questions and answers
When was Fixcet Spinal Facet Screw System cleared by the FDA?
Fixcet Spinal Facet Screw System (K100154) received a 510(k) decision of Substantially Equivalent on May 21, 2010, 121 days after the submission was received.
What is the product code of K100154?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.