FDA 510(k) Applications for Medical Device Product Code "OBT"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K093442 | ORTHOFIX INC. | GUIDED GROWTH SYSTEM | 06/10/2010 |
K110805 | ORTHOFIX INC. | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | 06/21/2011 |
K172183 | Orthofix Srl | Guided Growth Plate System Plus | 01/09/2018 |
K180624 | Orthofix Srl | Guided Growth Plate System Plus | 05/15/2018 |
K220190 | Pega Medical, Inc. | The GIRO Growth Modulation System | 10/24/2022 |
K182704 | WishBone Medical | WishBone Guided Growth System | 06/25/2019 |