Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005726885

FEI Number

3005726885

Entity Name

TEDAN SURGICAL INNOVATIONS, INC.

City/State/Country

Sugar Land, TX, US

Establishment Address

12320 Cardinal Meadow Drive, Suite #150, Sugar Land, TX 77478, US

Establishment Type(s)

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

Owner / Operator

TEDAN SURGICAL INNOVATIONS, INC. (Owner Number: 9086980)

Owner / Operator Contact Address

12320 Cardinal Meadow Drive, Suite #150, Sugar Land, TX 77478, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROBE INSTRUMENT TRAY ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY VARIOUS TYPES OF RETRACT RETRACTOR PHANTOM XL INSULATED DILATORS SURGICAL CURETTE PHANTOM ML LIGHT CABLE DRIVER, SURGICAL, PIN MDE - Arm SCREWDRIVER INSTRUMENTS, SURGICAL, CARDIOVASCULAR ULTRA VISION RETRACTOR SYSTEM CALIPERS FOR MEASURING BO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXB	Probe	Orthopedic	Class 1	888.4540	2012-12-20
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-11-23
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-12-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-05-09
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2007-11-23
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2014-11-21
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2007-11-23
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2009-12-15
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2008-12-10
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2008-12-10
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2008-12-10
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2014-06-02
KTZ	Caliper	Orthopedic	Class 1	888.4150	2006-05-09

Official Correspondent

Lynne Davies

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TEDAN SURGICAL INNOVATIONS, 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
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-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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
2134947	GAUTHIER BIOMEDICAL, INC.	Grafton, WI, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
1421879	PHOENIX INSTRUMENTS, INC.	Lisle, IL, US
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3015516266	Depuy Ireland UC	Co. Cork Munster, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005726885. Last updated year: 2026. Please use registration number 3005726885 when referencing this establishment in official correspondence.