Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml— 510(k) K150607

Substantially Equivalent

Osseon, LLC

FDA 510(k) clearance K150607 for Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml, Substantially Equivalent on 2015-04-09. Applicant: Osseon, LLC.

Clearance details

Applicant: Osseon, LLC
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2015-03-10
Decision date: 2015-04-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Rosa, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

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.