FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FIXCET SPINAL FACET SCREW SYSTEM
K Number: K100154
·
Decision May 21, 2010
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
34
Review Days
121
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Basic Information
- Device Name
- FIXCET SPINAL FACET SCREW SYSTEM
- K Number
- K100154
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- X-Spine Systems, Inc.
- Date Received
- January 20, 2010
- Decision Date
- May 21, 2010
- Product Code
- MRW
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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Other Clearances by X-Spine Systems, Inc.
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|---|---|---|---|
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| K170119 | Calix Lumbar Spinal Implant System | Sep 29, 2017 | Substantially Equivalent |
| K171567 | IRIX-A Lumbar Integrated Fusion System | Aug 28, 2017 | Substantially Equivalent |
| K171075 | Calix-C Cervical Interbody Spacer | Aug 1, 2017 | Substantially Equivalent |
| K170224 | Spider Cervical Plating System | Jul 6, 2017 | Substantially Equivalent |
| K170530 | Butrex Lumbar Buttress Plating System | Mar 22, 2017 | Substantially Equivalent |
| K160959 | Xsert Lumbar Expandable Interbody System | Nov 17, 2016 | Substantially Equivalent |
| K162944 | Irix-C Cervical Integrated Fusion System | Nov 7, 2016 | Substantially Equivalent |
| K160428 | Certex Spinal Fixation System | May 5, 2016 | Substantially Equivalent |