Submission Details
| 510(k) Number | K180361 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 09, 2018 |
| Decision Date | May 30, 2018 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
MICRORAPTOR REGENESORB Suture Anchor
May 2018
Decision
110d
Days
Class 2
Risk
About This 510(k) Submission
K180361 is an FDA 510(k) clearance for the MICRORAPTOR REGENESORB 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 May 30, 2018, 110 days after receiving the submission on February 9, 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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