Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026032087

FEI Number

3026032087

Entity Name

TOETAL SOLUTIONS, INC

City/State/Country

Malvern, PA, US

Establishment Address

7 Great Valley Pkwy Ste 295, Malvern, PA 19355, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Toetal Solutions, Inc (Owner Number: 10095176)

Owner / Operator Contact Address

7 Great Valley Parkway, Suite 295, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253325

PMA Number

N/A

All Registered Proprietary Names

ZipToe Hammertoe Fusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-02-03

Official Correspondent

Kaileen Osisek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Toetal Solutions, 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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.

Similar Registrations

Registration Number	Establishment Name	Location
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE
8043862	AAP IMPLANTATE AG	BERLIN, DE
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015231789	Arthrex Manufacturing Inc.	Pendleton, SC, US
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026032087. Last updated year: 2026. Please use registration number 3026032087 when referencing this establishment in official correspondence.