CONEXTIONS INC

FDA Device Registration & Listing · Salt Lake City, UT, US · Registration 3015718210

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015718210
FEI Number
3015718210
Entity Name
CONEXTIONS INC
City/State/Country
Salt Lake City, UT, US
Establishment Address
150 N Wright Brothers Drive, Suite 560, Salt Lake City, UT 84116, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
CoNextions Medical Corp (Owner Number: 10064174)
Owner / Operator Contact Address
150 N Wright Brothers Drive, Suite 560, Salt Lake City, UT 84116, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200028
PMA Number
N/A

All Registered Proprietary Names

CoNextions TR Tendon Repair System Coronet

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2022-04-26
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-03-24
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-03-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-24
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-03-24
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2020-03-24

Official Correspondent

Jesus Urdaneta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CoNextions Medical Corp
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K153770 In2bones Sas OS2(R)-VP Varisation Staple 2016-03-21
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2023 Synthes (USA) Products LLC 2
Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

Similar Registrations

Registration Number Establishment Name Location
3011689956 DYLAN LUCAS INTERNATIONAL INC Vaughan Ontario, CA
1061124 Sterigenics U.S., LLC Charlotte, NC, US
2029275 Sterigenics U.S., LLC Corona, CA, US
1000274611 INTERNACIONAL FARMACEUTICA, S.A. DE C.V. Mexico City, MX
3011276344 SWEDEN & MARTINA INC Naperville, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015718210. Last updated year: 2026. Please use registration number 3015718210 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.