PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON— 510(k) K122503

Substantially Equivalent

Neuro Therm, Inc.

FDA 510(k) clearance K122503 for PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON, Substantially Equivalent on 2013-06-25. Applicant: Neuro Therm, Inc..

Clearance details

Applicant: Neuro Therm, Inc.
Product code: Code NDN
Advisory panel: Orthopedic
Date received: 2012-08-16
Decision date: 2013-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ashland, MA, 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.