Panels › Orthopedic › Product code OBT · Class 2
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Regulation 888.3030
0510(k)s in 12 months (6 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OBT
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthofix Srl | 4 | 0 |
| Wishbone Medical | 1 | 1 |
| Pega Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 24, 2022 | K220190 | The GIRO Growth Modulation System Pega Medical, Inc., CA | OBT |
| Jun 25, 2019 | K182704 | WishBone Guided Growth System Wishbone Medical | OBT |
| May 15, 2018 | K180624 | Guided Growth Plate System Plus Orthofix Srl, IT | OBT |
| Jan 9, 2018 | K172183 | Guided Growth Plate System Plus Orthofix Srl, IT | OBT |
| Jun 21, 2011 | K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) Orthofix, Inc. | OBT |
| Jun 10, 2010 | K093442 | GUIDED GROWTH SYSTEM Orthofix, Inc. | OBT |
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