3 results
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26ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053
FDA Enforcement
Class II
·Ongoing·OrthoPediatrics Corp·August 5, 2020
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
FDA Enforcement
Class II
·Ongoing·OrthoPediatrics Corp·September 14, 2022
Orthex Large Bone Shoulder Bolt, model no. AS-17
FDA Enforcement
Class II
·Ongoing·OrthoPediatrics Corp·February 22, 2023