FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNIVision system
K Number: K203751
·
Decision Apr 12, 2021
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
57
Review Days
110
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
- OMNIVision system
- K Number
- K203751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- December 23, 2020
- Decision Date
- April 12, 2021
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.
Dynamis Robotic Surgical System
FDA 510(k)
FDA Class 2
·Neurology
CORUS Navigation System-GN
FDA 510(k)
FDA Class 2
·Neurology
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Navigated LLIF Impactable Tracker
FDA 510(k)
FDA Class 2
·Neurology
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
FDA 510(k)
FDA Class 2
·Neurology
Ion-C Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Corin USA
| K Number | Device Name | ||
|---|---|---|---|
| K202805 | Optimized Positioning System (OPS) Insight | Nov 20, 2020 | Substantially Equivalent |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | Aug 4, 2020 | Substantially Equivalent |
| K193042 | Optimized Positioning System (OPS) ReView | Jun 26, 2020 | Substantially Equivalent |
| K192656 | Optimized Positioning System (OPS) Insight | May 1, 2020 | Substantially Equivalent |
| K190143 | LARS AC Band Device | Nov 4, 2019 | Substantially Equivalent |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Jul 22, 2019 | Substantially Equivalent |
| K183038 | Corin Optimized Positioning System (OPS) Plan | Nov 26, 2018 | Substantially Equivalent |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | Sep 7, 2018 | Substantially Equivalent |
| K152893 | Corin Optimized Positioning System (OPS) | Jun 3, 2016 | Substantially Equivalent |
| K152903 | REVIVAL(TM) Modular Revision Hip Stem | Apr 29, 2016 | Substantially Equivalent |