FDA Product Code
FDA Product Code OBT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220190 | The GIRO Growth Modulation System | Pega Medical, Inc. | 2022-10-24 | Traditional | PDF ↗ |
| K182704 | WishBone Guided Growth System | Wishbone Medical | 2019-06-25 | Traditional | PDF ↗ |
| K180624 | Guided Growth Plate System Plus | Orthofix Srl | 2018-05-15 | Special | PDF ↗ |
| K172183 | Guided Growth Plate System Plus | Orthofix Srl | 2018-01-09 | Traditional | PDF ↗ |
| K110805 | GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) | Orthofix, Inc. | 2011-06-21 | Special | PDF ↗ |
| K093442 | GUIDED GROWTH SYSTEM | Orthofix, Inc. | 2010-06-10 | Special | PDF ↗ |
Product code OBT · Class II · Orthopedic. Data: openFDA.