HURON TOOL & CUTTER GRINDING

FDA Device Registration & Listing · Farmingdale, NY, US · Registration 3004358587

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004358587
FEI Number
3004358587
Entity Name
HURON TOOL & CUTTER GRINDING
City/State/Country
Farmingdale, NY, US
Establishment Address
485 Smith Street, Farmingdale, NY 11735, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HURON TOOL & CUTTER GRINDING (Owner Number: 10043479)
Owner / Operator Contact Address
485 SMITH STREET, Farmingdale, NY 11735, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DRILL BIT CANN AO 2X65MM ST DRILL BIT CANN AO 2X65MM NS DRILL HEAD RELIEF AO 2.5 NS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-02-20
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2013-02-20
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-12-29
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2021-02-11
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-12-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-03-18
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-12-30
HXX Screwdriver Orthopedic Class 1 888.4540 2025-12-29
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2016-01-13
OOG Knee Arthroplasty Implantation System Orthopedic Class 2 888.3560 2016-01-13
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-12-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-12-30
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-12-30
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2013-12-30
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-12-30
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-12-29

Official Correspondent

DANIELLE AVENA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HURON TOOL & CUTTER GRINDING
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
K223112 Smith & Nephew, Inc. MAVERICK Mini External Fixation System 2022-12-08
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0040-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011 Smith & Nephew, Inc. Endoscopy Division 1
Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004358587. Last updated year: 2026. Please use registration number 3004358587 when referencing this establishment in official correspondence.
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