Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010887276

FEI Number

3010887276

Entity Name

ICONN ORTHOPEDICS, LLC

City/State/Country

Birmingham, AL, US

Establishment Address

400 Union Hill Dr Ste 150, Birmingham, AL 35209, US

Establishment Type(s)

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

Owner / Operator

ICONN Orthopedics, LLC (Owner Number: 10046864)

Owner / Operator Contact Address

400 Union Hill Drive, Suite 150, Birmingham, AL 35209, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182264

PMA Number

N/A

All Registered Proprietary Names

ICONN Answer II Suture Anchor ICONN Instrument Tray (200001/2) ICONN Answer 4.75/5.5MM Suture Anchor Awl (247502) ICONN Square Suture Anchor Drill - Hard Bone, Rigid (225002HR) ICONN Revolution Knotless Suture Anchor Awl (351004) ICONN Square Suture Anchor Drill - Rigid (225002R) ICONN Answer II Awl/Tap (247509) ICONN Square Suture Anchor Drill (225002) ICONN Square Suture Anchor Drill - Hard Bone (225002H) ICONN Square Fish Mouth Drill Guide - Straight (225004SS) ICONN Square Crown Tip Drill Guide - Straight (225003SH) ICONN Square Fish Mouth Drill Guide - Curved (225004CS) ICONN Revolution Knotless Suture 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	2018-10-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-03-26
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-07-11
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2025-12-15
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2025-12-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-04-30

Official Correspondent

Whitt Israel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ICONN Orthopedics, LLC

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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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 3010887276. Last updated year: 2026. Please use registration number 3010887276 when referencing this establishment in official correspondence.