OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML— 510(k) K141930

Substantially Equivalent

Osseon, LLC

FDA 510(k) clearance K141930 for OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML, Substantially Equivalent on 2014-08-21. Applicant: Osseon, LLC.

Clearance details

Applicant: Osseon, LLC
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2014-07-16
Decision date: 2014-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Rosa, CA, US

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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.