Submission Details
| 510(k) Number | K200587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 06, 2020 |
| Decision Date | August 25, 2020 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
Aug 2020
Decision
172d
Days
Class 2
Risk
About This 510(k) Submission
K200587 is an FDA 510(k) clearance for the VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder, a Intraoperative Orthopedic Joint Assessment Aid (Class II — Special Controls, product code ONN), submitted by Orthosensor, Inc. (Dania Beach, US). The FDA issued a Cleared decision on August 25, 2020, 172 days after receiving the submission on March 6, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.
Device Classification
| Product Code | ONN — Intraoperative Orthopedic Joint Assessment Aid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Measurement And Interpretation Of Orthopedic Joint Information. |
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