Data / Medical devices / United States / Simparo, Inc
Simparo, Inc: FDA-registered device maker in Mobile, AL, United States, 1 510(k) clearance
Simparo, Inc is registered with the FDA (registration 3029312837) in Mobile, AL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029312837
- Address
- 1125 Corporate Drive Suite 2-B, Mobile, AL, United States, 36607
- Owner or operator
- Simparo, Inc (10088755)
- Roles
- Specification developer
- First device listed
- October 8, 2023
- Registered through
- 2026
- Brand names listed
- Anchor Line CMC Suspensionplasty System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 4, 2023 | K222574 | Simparo Anchor Line Fixation System | MBI | Substantially Equivalent | Simparo, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 4, 2023. 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.