MEDTRONIC POWERED SURGICAL SOLUTIONS

FDA Device Registration & Listing · FORT WORTH, TX, US · Registration 1625507

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
1625507
FEI Number
1625507
Entity Name
MEDTRONIC POWERED SURGICAL SOLUTIONS
City/State/Country
FORT WORTH, TX, US
Establishment Address
4620 NORTH BEACH ST., FORT WORTH, TX 76137, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K072315
PMA Number
N/A

All Registered Proprietary Names

MR8 Drill System Midas Rex MR8 ClearView Tools Bone Mill Midas Rex Legend Clearview Tools Midas Rex Legend Attachments Midas Rex Legend Curved Burs Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill Systems incorporating various Pneumatic Handpieces Midas Rex Legend Surgical Dissecting Tools PTEYE PARATHYROID AUTOFLUORESCENCE DETECTION DEVICE Stealth-Midas System Medtronic Electric Handpiece Midas Rex Legend Pneumatic System Midas Rex Classic system Midas Rex Legend Surgical Dissecting Tools IPC - Integrated Power Console Drill System Clearview Surgical Dissecting Tools Midas Rex Legend Attachments Midas Rex Legend Drill System Stealth-Midas MR8 System Irrigation Tubing Sets Saw Blades Saw Handpieces (Reciprocating, Oscillating, Sagittal) Microsaw Rasps Integrated Power Console Foot Control Cooling Tubing Sets Cranial/Ortho/Neuro Elec Drill Sys Triton Electric High Torque Handpiece And Accessories MR7 System Midas Rex MR8 Pneumatic and Electric Drill System Legend Pneumatic Cable Midas Rex Curved Burs

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2019-05-22
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2019-05-22
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2019-05-22
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2019-05-22
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2019-05-22
LYS Bone Mill Orthopedic Class 1 888.4540 2006-09-06
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2017-05-05
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2017-05-05
KFK Saw, Pneumatically Powered General, Plastic Surgery Class 1 878.4820 2017-05-05
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-05-05
GET Motor, Surgical Instrument, Pneumatic Powered General, Plastic Surgery Class 1 878.4820 2017-05-05
DWH Blade, Saw, Surgical, Cardiovascular General, Plastic Surgery Class 1 878.4820 2017-05-05
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2017-05-05
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-05-05
QDF Parathyroid Autofluorescence Detection Device General, Plastic Surgery Class 2 878.4550 2020-03-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-09-01
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2006-04-06
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2006-04-06
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2007-12-20
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2007-12-27
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-05-30
HRX Arthroscope Orthopedic Class 2 888.1100 2017-05-30
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2017-05-30
KFK Saw, Pneumatically Powered General, Plastic Surgery Class 1 878.4820 2017-05-30
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2017-05-30
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2017-05-30
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-05-30
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-05-24
HRX Arthroscope Orthopedic Class 2 888.1100 2008-10-27
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2008-10-27
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2008-10-27
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2008-10-27
HRX Arthroscope Orthopedic Class 2 888.1100 2015-08-05
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-08-05
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2015-08-05
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2015-08-05
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2009-12-14
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2017-05-05
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2017-05-05
HBC Motor, Drill, Electric Neurology Class 2 882.4360 2017-05-05
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2017-05-05
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-05-05
GET Motor, Surgical Instrument, Pneumatic Powered General, Plastic Surgery Class 1 878.4820 1996-02-06
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2007-12-27
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2007-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K253772 Adeor Medical AG Velocity Alpha MR High Speed Surgical Drill System 2026-03-06
K964548 Linvatec Corp. APEX UNIVERSAL DRIVE SYSTEM 1997-01-17
K953432 Midas Rex Pneumatic Tools, Inc. ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS 1995-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2026 Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany 2
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Z-0027-2026 Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany 2
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.

Similar Registrations

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9610612 AESCULAP AG TUTTLINGEN, DONAU Baden-Wurttemberg, DE
1649518 Sterigenics US LLC Fort Worth, TX, US
3010155648 Synergy Health Sterilisation UK Ltd West Yorkshire Bradford, GB
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1625507. Last updated year: 2026. Please use registration number 1625507 when referencing this establishment in official correspondence.
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