Optimized Positioning System (OPS) Insight
FDA 510(k) K202805 · Corin USA
510(k) numberK202805
Submission
- Device name
- Optimized Positioning System (OPS) Insight
- Applicant
- Corin USA
Tampa, FL, US - Received
- September 23, 2020
- Decision date
- November 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K203751 | OMNIVision systemOLO · Traditional | 04/12/2021SE |
| K193545 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 08/04/2020SE |
| K193042 | Optimized Positioning System (OPS) ReViewLLZ · Traditional | 06/26/2020SE |
| K192656 | Optimized Positioning System (OPS) InsightLLZ · Traditional | 05/01/2020SE |
| K190143 | LARS AC Band DeviceHTN · Traditional | 11/04/2019SE |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA)LZO · Traditional | 07/22/2019SE |
| K183038 | Corin Optimized Positioning System (OPS) PlanLLZ · Traditional | 11/26/2018SE |
| K181061 | Corin Optimized Positioning System (OPS) FemoralLZO · Traditional | 09/07/2018SE |
| K152893 | Corin Optimized Positioning System (OPS)LZO · Traditional | 06/03/2016SE |
| K152903 | REVIVAL(TM) Modular Revision Hip StemLZO · Traditional | 04/29/2016SE |
Questions and answers
When was Optimized Positioning System (OPS) Insight cleared by the FDA?
Optimized Positioning System (OPS) Insight (K202805) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 58 days after the submission was received.
What is the product code of K202805?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.