FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K Number: K113362
·
Decision Feb 10, 2012
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
9
Review Days
87
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Basic Information
- Device Name
- SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
- K Number
- K113362
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine View, Inc.
- Date Received
- November 15, 2011
- Decision Date
- February 10, 2012
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Spine View, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160856 | SpineView X-Pac Expandable Lumbar Cage System | Aug 1, 2016 | Substantially Equivalent |
| K152539 | SpineView X-Pac Expandable Lumbar Cage System | Feb 24, 2016 | Substantially Equivalent |
| K122134 | FLEXLITE CAMERA | Dec 27, 2012 | Substantially Equivalent |
| K121548 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | Aug 16, 2012 | Substantially Equivalent |
| K120680 | ENSPIRE DISCECTOMY SYSTEM | Jun 26, 2012 | Substantially Equivalent |
| K110992 | ENSPIRE DEBRIDER SYSTEM | Oct 21, 2011 | Substantially Equivalent |
| K090278 | ENSPIRE DEBRIDER SYSTEM | Apr 15, 2009 | Substantially Equivalent |
| K081051 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE | Aug 7, 2008 | Substantially Equivalent |