Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009822485

FEI Number

3009822485

Entity Name

Modern Surgical Instruments LLC

City/State/Country

Westerville, OH, US

Establishment Address

6295 MAXTOWN RD STE 700, Westerville, OH 43082, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Modern Surgical Instruments LLC (Owner Number: 10048427)

Owner / Operator Contact Address

6295 Maxtown Rd., Suite 700, Westerville, OH 43082, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elevator Nasal Forceps Mallet Curette BB Micro Curette Forceps Single Use Non-Stick Bipolar Forceps Bayonet Gauge Curette Dissector Trocar Retraction Blade Curette Frazier Suction Tip, Teardrop Type, 6FR, Natural Color, Sterile Trocar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2017-03-27
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-08-09
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-07-29
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-08-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-01-12
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2017-03-23
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2022-07-29
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-07-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-05-18
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2022-09-07
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-07-29
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-07-29
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2022-07-29
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2022-07-29
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2022-07-29
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2022-04-29
KBG	Trocar, Sinus	Ear, Nose, Throat	Class 1	874.4420	2022-08-10

Official Correspondent

Scott Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Modern Surgical Instruments 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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 3009822485. Last updated year: 2026. Please use registration number 3009822485 when referencing this establishment in official correspondence.