Data / Medical devices / United States / Conextions Inc

Conextions Inc: FDA-registered device maker in Salt Lake City, UT, United States, 2 510(k) clearances

Name: Conextions Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Conextions Inc is registered with the FDA (registration 3015718210) in Salt Lake City, UT, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 22, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015718210
Address: 150 N Wright Brothers Drive, Suite 560, Salt Lake City, UT, United States, 84116
Owner or operator: CoNextions Medical Corp (10064174)
Roles: Complaint file establishment, Manufacturer
First device listed: March 24, 2020
Registered through: 2026
Brand names listed: CoNextions TR Tendon Repair System, Coronet

Devices it lists

Device	Product code	Class	Role	Source
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Retention Device, Suture	KGS	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	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
April 22, 2022	K203855	CoNextions TR Tendon Repair System	GAQ	Substantially Equivalent	Conextions Medical	accessdata.fda.gov
March 4, 2020	K200028	Coronet Soft Tissue Fixation System	MBI	Substantially Equivalent	Conextions Medical	accessdata.fda.gov

Compare with other makers

Updated April 22, 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.