Data / Medical devices / United States / Surgical Innovation Associates, Inc.
Surgical Innovation Associates, Inc.: FDA-registered device maker in Chicago, IL, United States, 1 510(k) clearance
Surgical Innovation Associates, Inc. is registered with the FDA (registration 3015194982) in Chicago, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015194982
- Address
- 445 W Erie St Suite 111, Chicago, IL, United States, 60654
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Specification developer
- First device listed
- January 31, 2023
- Registered through
- 2026
- Brand names listed
- DuraSorb Monofilament Mesh
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | 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 |
|---|---|---|---|---|---|---|
| August 2, 2018 | K181094 | Polydioxanone Surgical Scaffold | FTL | Substantially Equivalent | Lntegra Lifesciences | accessdata.fda.gov |
Compare with other makers
Updated August 2, 2018. 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.