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The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).

The subject device includes several different designs of implantable distractors intended for bone lengthening or stabilization. The subject device is not supplied sterile. The subject device consists of: Transpalatal Distractor TPB (Module Size #1 (1 - 21mm), Module Size# 2 (16 - 31mm), Module Size# 3 (22 - 49mm), Module Size# 4 (26 - 59mm), Abutment Plate, Osteosynthesis Screws); Transmandibular Distractor TMD (Vertical Footplates with rods, Osteosynthesis Screws); Mandibular Distraction Dynamic Osteosynthesis MD-DOS (Posterior Fixation Unit (PFU), Fixation Screws, Distraction Unit (DU), Anterior Fixation Unit (AFU), Spacer). The subject device requires patient activation at specified times post-operatively using a provided spanner. The device is composed of Titanium Allov Grade 2 and 5 per ASTM F-67 and ASTM F-136 requirements.