Skip to the page

Data / Medical devices / United States / Woven Orthopedic Technologies

Woven Orthopedic Technologies: FDA-registered device maker in Stamford, CT, United States, 2 510(k) clearances

Woven Orthopedic Technologies is registered with the FDA (registration 3017505709) in Stamford, CT, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 26, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3017505709
Address
750 E Main St Ste 620, Stamford, CT, United States, 06902
Owner or operator
Woven Orthopedic Technologies (10081391)
Roles
Complaint file establishment, Specification developer
First device listed
July 13, 2023
Registered through
2026
Brand names listed
Ogmend, Ogmend Implant, Ogmend Implant Enhancement System, Ogmend Insterter

Devices it lists

DeviceProduct codeClassRoleSource
Screw Sleeve Bone Fixation Device, SpineQVI2Complaint file establishment, Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 26, 2023K233223OGmend® Implant Enhancement SystemQVISubstantially EquivalentWoven Orthopedic Technologiesaccessdata.fda.gov
February 27, 2023K223075Ogmend® Implant Enhancement SystemQVISubstantially EquivalentWoven Orthopedic Technologiesaccessdata.fda.gov

Updated October 26, 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.