FDA Registration
Active
🇺🇸 United States
Millstone Medical Outsourcing LLC
Reg #: 3010097171
·
FEI: 3010097171
·
Expires 2026
Products
145
Proprietary Names
45
Establishment Types
1
Classifications
145
Registration Details
- Registration Name
- Millstone Medical Outsourcing LLC
- Registration Number
- 3010097171
- FEI Number
- 3010097171
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8836 Polk Lane, Suite 100
- City
- Olive Branch
- State
- MS
- ZIP
- 38654
- Country
- US
Owner / Operator
- Firm Name
- MILLSTONE MEDICAL OUTSOURCING LLC.
- Operator Number
- 9042927
- Address
- 580 Commerce Drive
- City
- Fall River
- State
- MA
- Postal Code
- 02720
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-02-04 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-02-04 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-08-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-08-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-08-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-12-20 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-12-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-12-20 |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2014-10-16 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2014-12-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-08-15 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-05-21 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-05-22 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2013-05-22 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-05-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-05-21 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2013-06-06 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2013-12-02 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-05-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-04-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-05-21 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-02-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2013-03-26 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-03-26 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-06-06 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2013-06-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-03-27 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-03-27 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2017-03-27 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2016-08-12 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2013-03-26 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2013-03-26 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2015-07-31 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-03-18 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-03-18 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2018-09-06 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2015-07-31 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2018-09-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-05-22 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2018-09-06 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2016-08-12 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2014-12-29 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2023-01-19 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-11-04 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-06-06 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-05-22 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-05-21 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2013-06-06 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-06-04 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2025-09-25 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2017-11-14 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-11-19 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-05-22 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2015-08-03 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2024-11-04 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-11-04 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-12-02 |
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2023-01-19 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-05-21 |
| Conformer, Ophthalmic, Biological Tissue | NQB | Class 2 | Ophthalmic | No | 2021-03-10 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2014-12-29 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2013-06-04 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2013-01-31 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-01-31 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2013-06-06 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2013-05-22 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-05-22 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2016-08-15 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2013-06-06 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2015-07-31 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2013-05-22 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2013-03-26 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-12-02 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2019-01-09 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2013-05-22 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2018-09-06 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2013-03-26 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2013-03-26 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-05-22 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2025-11-17 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-11-17 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2025-11-17 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2025-11-17 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2025-11-17 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2025-11-17 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2025-11-17 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-05-22 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2014-03-21 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-05-21 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-07-05 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2013-02-19 |
| Brush, Dermabrasion, Manual | GED | Class 1 | General, Plastic Surgery | No | 2013-06-06 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2018-09-06 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2014-03-21 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Complement C4, Antigen, Antiserum, Control | DBI | Class 2 | Immunology | No | 2013-03-26 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2014-03-21 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-05-21 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Fork | HXE | Class 1 | Orthopedic | No | 2016-08-12 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2013-03-26 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2018-07-20 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2015-07-31 |
| Retainer, Surgical | GCZ | Class 1 | General, Plastic Surgery | No | 2018-09-06 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-02-04 |
| Punch, Femoral Neck | HWP | Class 1 | Orthopedic | No | 2013-06-06 |
| Block, Cutting, Ent, Sterile | JXS | Class 1 | Ear, Nose, Throat | No | 2014-03-21 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2021-04-08 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2013-05-22 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2013-06-06 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2025-11-19 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-05-21 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2016-08-12 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
Proprietary Names
MALLET, SURGICAL
Indus invue ACP System/ invue ACP System/ Indus ACP System
GOUGE
Prosthesis, hip, semi-constrained, metal/polymer, uncemented
Driver
BURR, ORTHOPEDIC
General Instrument
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
PASSER, WIRE, ORTHOPEDIC
general instrument
LABEL OR TAG, STERILE
RegenerOss
Clamp
PUSHER, SOCKET
INSTRUMENT, BENDING OR CONTOURING
SCISSORS, ORTHOPEDIC, SURGICAL
GUIDE
DRIVER, SURGICAL PIN
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
TRAY, SURGICAL
BROACH
RASP, SURGICAL
Dorado TLIF Intervertebral Body Cage System/ Vega Span Spinous Process Plate/ Arena-L ALIFT Lumbar IBF System/ DORADO E-
DRAPE, SURGICAL
Manual Surgical Instrument, Multipl
FORCEPS
Calculator/Data Processing Module, For Clinical Use- i-STAT Alinity Charge Station
HEMOSTAT
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Arena-C HA PEEK Cervical IBFD
GDG / HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
FORCEPS, WIRE HOLDING
i-STAT-1 Analyzer
RETRACTOR
TAPE, MEASURING, RULERS AND CALIPERS/ Rod Caliper
COMPLEMENT C4, ANTIGEN, ANTISERUM, CONTROL
Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
Hearing aid, bone conduction
Arena-C
CONTROLLER, FOOT, HANDPIECE AND CORD
KNIFE, ORTHOPEDIC
PUNCH, FEMORAL NECK
INSTRUMENT, SURGICAL, DISPOSABLE
ELEVATOR
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)