Data / Medical devices / Splint, Abduction, Congenital Hip Dislocation / United States
FDA-registered makers of Splint, Abduction, Congenital Hip Dislocation in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Splint, Abduction, Congenital Hip Dislocation (product code IOZ). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Splint, Abduction, Congenital Hip Dislocation
- Product code
- IOZ
- Country
- United States
Makers of Splint, Abduction, Congenital Hip Dislocation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alex Orthopedic, Inc. | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfortland International, LLC | Mebane, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Medical Products, Inc. | Plainville, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthomerica Products, Inc. | Orlando, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Restorative Care Of America, Inc. | Saint Petersburg, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span-America Medical Systems, Inc. | Greenville, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiburon Medical Enterprises | San Jacinto, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trulife, Inc. | Bellingham, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wheaton Brace Company | Carol Stream, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.