Data / Medical devices / United States / Surestep, LLC
Surestep, LLC: FDA-registered device maker in South Bend, IN, United States, 1 510(k) clearance
Surestep, LLC is registered with the FDA (registration 3003895329) in South Bend, IN, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003895329
- Address
- 17530 Dugdale DR, South Bend, IN, United States, 46635
- Owner or operator
- SURESTEP, LLC (10028081)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 29, 2008
- Registered through
- 2026
- Brand names listed
- CUSTOM MOLDED FOOT ORTHOSIS, SURESTEP, SureStep TLSO, Surestep
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Cervical | IQK | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthosis, Corrective Shoe | KNP | 1 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Orthosis, Cranial | MVA | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Cranial, Laser Scan | OAN | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2022 | K203134 | Hanger Cranial Band 3D | MVA | Substantially Equivalent | Symbion Logistics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Limb Brace
- All makers of Orthosis, Truncal/Orthosis, Limb
- All makers of Orthosis, Corrective Shoe
- All makers of Orthosis, Cervical
- All makers of Orthosis, Cranial
- All makers of Orthosis, Cranial, Laser Scan
Updated July 1, 2022. 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.