Data / Medical devices / United States / Ziptek LLC
Ziptek LLC: FDA-registered device maker in Sarasota, FL, United States, 1 510(k) clearance
Ziptek LLC is registered with the FDA (registration 3013722959) in Sarasota, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013722959
- Address
- 1250 S Tamiami TRL Ste 303, Sarasota, FL, United States, 34239
- Owner or operator
- ZIPTEK LLC (10055345)
- Roles
- Specification developer
- First device listed
- July 10, 2017
- Registered through
- 2026
- Brand names listed
- ZipE, zipe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Specification developer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | 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 |
|---|---|---|---|---|---|---|
| March 13, 2017 | K162429 | ZipE Knotless Tissue Repair and Attachment Devices | MAI | Substantially Equivalent | Ziptek, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Retention Device, Suture
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated March 13, 2017. 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.