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

Name: FDA 510(k) clearance K954338
Creator: U.S. Food and Drug Administration
Published: 1996-03-21

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.. Device class: 2.

Clearance details

Applicant: Innovasive Devices, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
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

Download summary PDF View on FDA.gov ↗

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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.