HNM Medical dba HNM TOTAL RECON

FDA Device Registration & Listing · Miami, FL, US · Registration 3009513193

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
3009513193
FEI Number
3009513193
Entity Name
HNM Medical dba HNM TOTAL RECON
City/State/Country
Miami, FL, US
Establishment Address
20855 NE 16th Ave Ste C15, Miami, FL 33179, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
HNM Medical (Owner Number: 10049219)
Owner / Operator Contact Address
20855 NE 16 Avenue, Suite C15, Miami, FL 33179, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM 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Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical Instrument HNM Medical Surgical 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Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-09-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-22
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2015-04-29
HTX Rongeur Orthopedic Class 1 888.4540 2018-05-22
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2017-10-09
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2025-02-18
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-12
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-12
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2018-05-21
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2018-05-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-05-22
GFB Head, Surgical, Hammer General, Plastic Surgery Class 1 878.4820 2018-05-22
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2018-05-22
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2018-05-21
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-08
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2018-05-22
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-07-26
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2017-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-04-29
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 2018-05-21
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2018-07-12
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2018-05-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-26
EKB Explorer, Operative Dental Class 1 872.4565 2018-05-21
KBQ Knife, Tonsil Ear, Nose, Throat Class 1 874.4420 2018-05-22
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2018-05-21
FNS Ring Cutter General Hospital Class 1 880.6200 2018-05-21
HXS Twister, Wire Orthopedic Class 1 888.4540 2018-05-21
FHA Clamp, Penile Gastroenterology, Urology Class 1 876.5160 2018-05-21
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2018-05-22
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2018-05-22
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2018-07-12
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2018-05-21
FHK Spreader, Bladder Neck Gastroenterology, Urology Class 1 876.4730 2018-05-22
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2016-04-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-11-30
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-11-30
PLF Bone Wedge Orthopedic Class 2 888.3030 2016-11-30
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-12
KAO Curette, Ethmoid Ear, Nose, Throat Class 1 874.4420 2018-05-21
HXW Bender Orthopedic Class 1 888.4540 2017-10-09
EXX Probe, Rectal, Non-Powered Gastroenterology, Urology Class 1 876.4730 2018-05-21
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-03-08
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-05
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2018-05-21
HXE Fork Orthopedic Class 1 888.4540 2024-01-30
KAG Holder, Speculum, Ent General, Plastic Surgery Class 1 878.1800 2018-05-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-22
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2018-05-21
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2018-05-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-11-28
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2017-11-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-11-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-11-28
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2018-05-21
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2018-05-21
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2018-05-22
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-05-22
HTD Forceps General, Plastic Surgery Class 1 878.4800 2017-10-09
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2018-05-21
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2018-05-21
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2018-05-21
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2018-05-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-05-16
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2018-05-22
LXI Guide, Drill, Ligament General, Plastic Surgery Class 1 878.4820 2018-05-21
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2018-05-21
HTW Bit, Drill Orthopedic Class 1 888.4540 2017-03-08
GAB Needle, Suturing, Disposable General, Plastic Surgery Class 1 878.4800 2018-05-21
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-21
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2018-07-12
FGN Retractor, Non-Self-Retaining Gastroenterology, Urology Class 1 876.4730 2018-05-21
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2018-05-22
FNY Basin, Emesis General Hospital Class 1 880.6730 2018-07-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-09-05
EIG Retractor, All Types Dental Class 1 872.4565 2018-05-21
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2018-05-21
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2018-05-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-08
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2018-05-21
FXP Cover, Shoe, Operating-Room General, Plastic Surgery Class 1 878.4040 2019-08-19
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-05-22
GDM Needle, Aspiration And Injection, Reusable General, Plastic Surgery Class 1 878.4800 2018-05-21
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-21
KBH Adenotome Ear, Nose, Throat Class 1 874.4420 2018-05-21
FAX Bougie, Urological Gastroenterology, Urology Class 1 876.5520 2018-05-21
HWX Tap, Bone Orthopedic Class 1 888.4540 2017-10-09
GAD Retractor General, Plastic Surgery Class 1 878.4800 2018-05-22
HWW Countersink Orthopedic Class 1 888.4540 2017-04-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-09-04
HXB Probe Orthopedic Class 1 888.4540 2018-05-22
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-22
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2015-07-05
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 2018-05-22
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 2018-05-21
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2018-05-21
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2018-07-12
ODR Electrosurgical Patient Return Electrode General, Plastic Surgery Class 2 878.4400 2018-05-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-05-22
JYY Rasp, Ear Ear, Nose, Throat Class 1 874.4420 2018-05-21
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2018-05-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-05-22
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2018-05-21
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2017-03-08
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2017-10-09
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2018-05-21
HNJ Punch, Corneo-Scleral Ophthalmic Class 1 886.4350 2018-05-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-03-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2017-03-08
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2018-05-22
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-11-19
HNE Snare, Enucleating Ophthalmic Class 1 886.4350 2018-05-21
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2015-04-29
JZB Scissors, Ear Ear, Nose, Throat Class 1 874.4420 2018-05-21
GDO Applier, Surgical, Clip General, Plastic Surgery Class 1 878.4800 2018-05-21
HDJ Scissors, Umbilical Obstetrics/Gynecology Class 1 884.4520 2018-05-21
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2018-05-22
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-05-22
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2015-07-05
HXL Mallet General, Plastic Surgery Class 1 878.4800 2018-07-12
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2018-05-21
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2018-05-21
NNN Crimper, Wire, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2018-05-21
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2018-05-21
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-22
FTX Mirror, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-21
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2018-05-22
KAN Chisel, Nasal General, Plastic Surgery Class 1 878.4800 2018-05-21
KCF Dilator, Esophageal, Ent Ear, Nose, Throat Class 1 874.4420 2018-05-21
KBS Punch, Adenoid Ear, Nose, Throat Class 1 874.4420 2018-05-21
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2018-05-21
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2018-05-21
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 2018-05-21
HTO Reamer Orthopedic Class 1 888.4540 2018-05-21
HHF Remover, Intrauterine Device, Contraceptive, Hook-Type Obstetrics/Gynecology Class 1 884.4530 2018-07-12
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2025-03-10
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2018-05-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-08-20
HXC Wrench Orthopedic Class 1 888.4540 2017-10-09
KBB Rongeur, Nasal Ear, Nose, Throat Class 1 874.4420 2018-05-21
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 2018-05-21
HXX Screwdriver Orthopedic Class 1 888.4540 2017-10-09
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2018-05-21
FHB Hook, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2018-05-21
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2018-05-21
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2018-07-12
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2018-05-22
GCZ Retainer, Surgical General, Plastic Surgery Class 1 878.4800 2025-12-18
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2018-05-22
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2018-05-21
HWO Skid, Bone Orthopedic Class 1 888.4540 2018-05-21
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2018-05-21
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-21
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2018-05-22
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2018-05-22
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2018-05-22
HXD Clamp General, Plastic Surgery Class 1 878.4800 2018-05-22
HDM Packer, Uterine Obstetrics/Gynecology Class 1 884.4520 2018-05-21
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2018-05-21
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-22
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2018-05-22
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2018-05-21
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2018-05-21
GWX Fork, Tuning Neurology Class 1 882.1525 2018-05-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-03-08
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2018-07-12
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2015-07-05
GEO File, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-05-21
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2018-05-21
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-07-12
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2018-05-22
HNZ Curette, Ophthalmic Ophthalmic Class 1 886.4350 2018-05-21
HWJ Awl Orthopedic Class 1 888.4540 2018-05-21
HWB Extractor Orthopedic Class 1 888.4540 2024-03-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-09-15
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2018-05-22
KAR Irrigator, Sinus Ear, Nose, Throat Class 1 874.4420 2018-05-21
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2018-05-22
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2015-04-29
KBC Saw, Nasal Ear, Nose, Throat Class 1 874.4420 2018-05-21
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2018-05-22
HTP File Orthopedic Class 1 888.4540 2018-05-21
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2018-05-21
HXG Tamp Orthopedic Class 1 888.4540 2018-05-21
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2018-05-21

Official Correspondent

Steven Skerritt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HNM Medical
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
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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
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009513193. Last updated year: 2026. Please use registration number 3009513193 when referencing this establishment in official correspondence.
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