Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor— 510(k) K163672

Substantially Equivalent

Nanova Biomaterials, Inc.

FDA 510(k) clearance K163672 for Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor, Substantially Equivalent on 2017-05-05. Applicant: Nanova Biomaterials, Inc..

Clearance details

Applicant: Nanova Biomaterials, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2016-12-27
Decision date: 2017-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.