Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030861184

FEI Number

3030861184

Entity Name

Tullo, LLC

City/State/Country

Macomb, MI, US

Establishment Address

22701 Hall Rd Ste 100, Macomb, MI 48042, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Tullo, LLC (Owner Number: 10090290)

Owner / Operator Contact Address

22701 Hall Rd., Suite 100, Macomb, MI 48042, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Shoulder-Side Entry Glenosphere Inserter, SEGI-3944 Facilitator Posterior Glenoid Retractor, Facilitator-Standard Facilitator Posterior Glenoid Retractor, Facilitator-Small Shoulder-Side Entry Glenosphere Inserter, SEGI-3338

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-03-08

Official Correspondent

Nicholas Schoch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tullo, 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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030861184. Last updated year: 2026. Please use registration number 3030861184 when referencing this establishment in official correspondence.