MAHE MEDICAL USA

FDA Device Registration & Listing · Laramie, WY, US · Registration 3013011598

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
3013011598
FEI Number
3013011598
Entity Name
MAHE MEDICAL USA
City/State/Country
Laramie, WY, US
Establishment Address
3821 Beech Street, Laramie, WY 82070, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Mahe Medical USA (Owner Number: 10052835)
Owner / Operator Contact Address
3821 Beech Street, Laramie, WY 82070, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K933770
PMA Number
N/A

All Registered Proprietary Names

MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE Cartilage Punch - Mahe MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE MAHE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2025-01-20
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-01-20
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
HTO Reamer Orthopedic Class 1 888.4540 2025-01-20
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2025-01-20
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2025-01-20
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2025-01-20
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2025-01-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-01-20
HWA Impactor Orthopedic Class 1 888.4540 2025-01-20
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-01-20
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-20
HXW Bender Orthopedic Class 1 888.4540 2025-01-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-01-20
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-01-20
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-01-20
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2025-01-20
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2025-01-20
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2025-01-20
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2025-01-20
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2025-01-20
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2025-01-20
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2025-01-20
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2025-01-20
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2025-01-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-01-20
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2025-01-20
FWF Camera, Television, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2025-01-20
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-01-20
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-20
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-01-20
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2025-01-20
HXJ Staple Driver Orthopedic Class 1 888.4540 2025-01-20
HWX Tap, Bone Orthopedic Class 1 888.4540 2025-01-20
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-01-20
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2025-01-20
HWB Extractor Orthopedic Class 1 888.4540 2025-01-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-01-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-20
HXX Screwdriver Orthopedic Class 1 888.4540 2025-01-20
HXC Wrench Orthopedic Class 1 888.4540 2025-01-20
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2025-01-20
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2025-04-16
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2025-01-20
HTE Elevator General, Plastic Surgery Class 1 878.4800 2025-01-20
EBL Pin, Retentive And Splinting, And Accessory Instruments Dental Class 1 872.3740 2025-01-20
HWT Template Orthopedic Class 1 888.4800 2025-01-20
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2025-01-20
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2024-12-30
GAD Retractor General, Plastic Surgery Class 1 878.4800 2025-01-20
HWW Countersink Orthopedic Class 1 888.4540 2025-01-20
HTF Curette General, Plastic Surgery Class 1 878.4800 2025-01-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-22
DWG Electrosurgical Device General, Plastic Surgery Class 2 878.4400 2025-01-20
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2025-01-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-01-20
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2025-01-20
HYA Forceps, Wire Holding General, Plastic Surgery Class 1 878.4800 2025-01-20
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2025-01-20

Official Correspondent

Keith Hamilton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mahe Medical USA
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
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17

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-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013011598. Last updated year: 2026. Please use registration number 3013011598 when referencing this establishment in official correspondence.
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