Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043861298

FEI Number

3043861298

Entity Name

SUTURE TECH, INC.

City/State/Country

Durham, NC, US

Establishment Address

810 Laurelwood Dr, Durham, NC 27705, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Suture Tech, Inc. (Owner Number: 10095388)

Owner / Operator Contact Address

810 Laurelwood Dr., Durham, NC 27705, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250095

PMA Number

N/A

All Registered Proprietary Names

RapidFix All-Suture Dual Anchor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-03-06

Official Correspondent

Okechukwu Anakwenze

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Suture Tech, Inc.

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
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Similar Registrations

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3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3011989923	DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI	Istanbul, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043861298. Last updated year: 2026. Please use registration number 3043861298 when referencing this establishment in official correspondence.