BIOROC EZ SUTURE BONE FASTENER— 510(k) K973381

Substantially Equivalent

Innovasive Devices, Inc.

FDA 510(k) clearance K973381 for BIOROC EZ SUTURE BONE FASTENER, Substantially Equivalent on 1998-02-18. Applicant: Innovasive Devices, Inc..

Clearance details

Applicant: Innovasive Devices, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1997-09-08
Decision date: 1998-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

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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.