Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025102

FEI Number

3004949275

Entity Name

Brasseler U.S.A. Medical, LLC

City/State/Country

Savannah, GA, US

Establishment Address

1 Brasseler Blvd, Savannah, GA 31419, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Brasseler U.S.A. Medical, LLC (Owner Number: 9010748)

Owner / Operator Contact Address

1 Brasseler Blvd, Savannah, GA 31419, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BRASSELER BURR, ORTHOPEDIC Arthrex Large Bone Sagittal Blade Stryker Total Ankle Reconstruction Blade BRASSELER BUR, SURGICAL, GENERAL & PLASTIC SURGERY SURGICAL BRASSELER SAW, PNEUMATICALLY POWERED BRASSELER Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment BRASSELER WRAP STERILIZATION BRASSELER LAVAGE, JET BRASSELER Orthopedic manual surgical instrument BRASSELER SAW, POWERED AND ACCESSORIES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2013-01-07
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2008-04-04
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2005-03-23
KFK	Saw, Pneumatically Powered	General, Plastic Surgery	Class 1	878.4820	2015-10-19
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2008-04-04
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2008-04-04
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2008-04-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	1999-04-28
LZV	System, Cement Removal Extraction	Orthopedic	Class 2	888.4580	2025-02-17
HAB	Saw, Powered, And Accessories	General, Plastic Surgery	Class 1	878.4820	1994-06-21

Official Correspondent

Carl Mazzolini

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Brasseler U.S.A. Medical, 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
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3005575604	SURETEK MEDICAL	GREENVILLE, SC, US
3038195984	BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.	Beijing, CN
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3007038972	MAT GMBH & CO. KG	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025102. Last updated year: 2026. Please use registration number 2025102 when referencing this establishment in official correspondence.