Data / Medical devices / Plate, Bone, Growth Control, Pediatric, Epiphysiodesis / United States
FDA-registered makers of Plate, Bone, Growth Control, Pediatric, Epiphysiodesis in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (product code OBT). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
- Product code
- OBT
- Country
- United States
Makers of Plate, Bone, Growth Control, Pediatric, Epiphysiodesis in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Orthofix Us LLC | Lewisville, TX, United States | Manufacturer for export, Repackager or relabeler, Specification developer | 4 | May 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Red Star Contract Manufacturing Inc. | Larwill, IN, United States | Complaint file establishment, Manufacturer | 1 | June 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Avalign Integrated Medical Solutions, Inc | Mentor, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fort Wayne Metals Research Products, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.