510(k) K122503

PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON by Neuro Therm, Inc. — Product Code NDN

K122503 is an FDA 510(k) premarket notification submitted by Neuro Therm, Inc. for the device "PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON". The FDA issued a decision of Substantially Equivalent on June 25, 2013. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Neuro Therm, Inc. has at least 2 other 510(k) clearances on record.