INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER— 510(k) K954338

Substantially Equivalent for Some Indications

Innovasive Devices, Inc.

FDA 510(k) clearance K954338 for INNOVASIVE 1.9MM ROC SUTURE BONE FASTENER, Substantially Equivalent for Some Indications on 1996-03-21. Applicant: Innovasive Devices, Inc..

Clearance details

Applicant: Innovasive Devices, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1995-09-18
Decision date: 1996-03-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Hopkinton, MA, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.