Submission Details
| 510(k) Number | K181746 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 02, 2018 |
| Decision Date | September 28, 2018 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
MICRORAPTOR Knotless Suture Anchor
Sep 2018
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K181746 is an FDA 510(k) clearance for the MICRORAPTOR Knotless Suture Anchor, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Smith and Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 28, 2018, 88 days after receiving the submission on July 2, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.
Device Classification
| Product Code | MAI — Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
Manufacturer
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