Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008747271

FEI Number

3008747271

Entity Name

TOBY ORTHOPAEDICS

City/State/Country

Miami, FL, US

Establishment Address

6355 SW 8th Street, Suite 101, Miami, FL 33144, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Toby Orthopaedics (Owner Number: 10028539)

Owner / Operator Contact Address

6355 SW 8TH STREET, SUITE 101, Miami, FL 33144, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Flexor Tendon Sheath Retractor TOBY- Sterilization Tray TOBY- SURGICAL RETAINER TOBY- Surgical Guides TOBY- Depth Gauge TOBY- Drill Bits TOBY- Surgical Instruments Tray TOBY- Drivers

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2009-02-10
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-03
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-03
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-01-03
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2013-01-03
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-03
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-03
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-03

Official Correspondent

Eduardo Gonzalez-Hernandez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Toby Orthopaedics

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

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.
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.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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 3008747271. Last updated year: 2026. Please use registration number 3008747271 when referencing this establishment in official correspondence.