FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRIX-A Lumbar Integrated Fusion System
K Number: K171567
·
Decision Aug 28, 2017
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
34
Review Days
90
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Basic Information
- Device Name
- IRIX-A Lumbar Integrated Fusion System
- K Number
- K171567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- X-Spine Systems, Inc.
- Date Received
- May 30, 2017
- Decision Date
- August 28, 2017
- Product Code
- OVD
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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| 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 |
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