Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015200653

FEI Number

3015200653

Entity Name

EXOTOE LLC

City/State/Country

Charlotte, NC, US

Establishment Address

520 Elliot St, Charlotte, NC 28202, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Exotoe LLC (Owner Number: 10059587)

Owner / Operator Contact Address

9220 NW 73rd St, Johnston, IA 50131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172205

PMA Number

N/A

All Registered Proprietary Names

ExoToe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-02-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exotoe 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
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21

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

Similar Registrations

Registration Number	Establishment Name	Location
3039081660	BLAZE BIOTECH, LLC	San Antonio, TX, US
3027848094	MENTOR SUPPLY CHAIN (USA) INC	Warsaw, IN, US
3014527966	F & A FOUNDATION	Tulsa, OK, US
1833920	INSTRU-MED TECHNOLOGIES	Warsaw, IN, US
1058584	Sterigenics US LLC	Charlotte, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015200653. Last updated year: 2026. Please use registration number 3015200653 when referencing this establishment in official correspondence.