FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXLITE CAMERA
K Number: K122134
·
Decision Dec 27, 2012
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
9
Review Days
162
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FLEXLITE CAMERA
- K Number
- K122134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine View, Inc.
- Date Received
- July 18, 2012
- Decision Date
- December 27, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Digital ClarusScope System and Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom DS Decompression System
FDA 510(k)
FDA Class 2
·Orthopedic
VantageTM Lumbar Decompression Kit
FDA 510(k)
FDA Class 2
·Orthopedic
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
FDA 510(k)
FDA Class 2
·Orthopedic
PUREVUE FMS
FDA 510(k)
FDA Class 2
·Orthopedic
Articulator Arthroscopic Bur
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K121548 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | Aug 16, 2012 | Substantially Equivalent |
| K120680 | ENSPIRE DISCECTOMY SYSTEM | Jun 26, 2012 | Substantially Equivalent |
| K113362 | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) | Feb 10, 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 |