Bone Growth Stimulator Reclassification Proceeding Sample Clauses

Bone Growth Stimulator Reclassification Proceeding. Orthofix Inc. is currently involved in a proceeding before the FDA addressing whether the regulatory classification of Orthofix Inc.'s Physio-Stim and Spinal-Stim bone growth stimulation products should be reclassified from FDA Class III to FDA Class II. Orthofix Inc. is actively participating in this proceeding and maintains that the current FDA Class III classification is correct. A meeting was held on June 2, 2006 before the FDA's Orthopedic and Rehabilitation Devices panel for the purpose of gathering information to allow the panel to recommend to the FDA whether reclassification is appropriate. At the conclusion of the meeting, the Panel determined that the present FDA Class III classification for the products at issue is proper. Orthofix Inc. does not know when or whether the FDA will reach a final determination on this classification issue or whether any such determination will adversely impact Orthofix Inc.'s ability to market or sell these products. 2. Breg Inc.