MICRORAPTOR REGENESORB Suture Anchor— 510(k) K180361
Substantially EquivalentSmith and Nephew, Inc.
FDA 510(k) clearance K180361 for MICRORAPTOR REGENESORB Suture Anchor, Substantially Equivalent on 2018-05-30. Applicant: Smith and Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith and Nephew, Inc.
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cordova, TN, US
Recent devices under product code MAI
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- K183232 — Double ENDOBUTTON Fixation Device
- K181746 — MICRORAPTOR Knotless Suture Anchor
Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.