FDA Registration
Active
🇺🇸 United States
MILLSTONE MEDICAL OUTSOURCING LLC.
Reg #: 1226544
·
FEI: 3003128516
·
Expires 2026
Products
133
Proprietary Names
50
Establishment Types
1
Classifications
133
Registration Details
- Registration Name
- MILLSTONE MEDICAL OUTSOURCING LLC.
- Registration Number
- 1226544
- FEI Number
- 3003128516
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 580 Commerce Dr
- City
- FALL RIVER
- State
- MA
- ZIP
- 02720
- 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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-02-07 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2013-05-22 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-05-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2023-12-20 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2026-02-27 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2026-02-27 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-02-06 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-02-06 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-02-04 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2013-05-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-05-22 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2019-05-22 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2013-12-03 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-02-07 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-02-04 |
| 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 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-05-22 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-05-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-12-06 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-12-06 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2013-02-07 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-02-07 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-05-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2019-05-22 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-12-06 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2024-12-06 |
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2026-05-29 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-12-03 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-05-21 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-02-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2021-04-01 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-12-02 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-12-02 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-10-26 |
| Prosthesis, Wrist, Hemi-, Ulnar | KXE | Class 2 | Orthopedic | No | 2013-02-07 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2017-03-27 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2017-03-27 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2024-12-06 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2016-01-27 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2017-02-09 |
| 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 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-05-20 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2024-12-06 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2019-05-22 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2024-12-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2015-08-19 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2015-08-19 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2015-08-19 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2015-08-19 |
| Semi-Constrained Metal/Polymer Finger Joint Prosthesis | MPK | Class f | Unknown | No | 2013-02-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-02-07 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2013-02-07 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2013-02-07 |
| Prosthesis, Finger, Constrained, Polymer | KYJ | Class 2 | Orthopedic | No | 2013-02-07 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2013-05-20 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2015-07-31 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2016-01-27 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2016-01-27 |
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2017-03-27 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2017-12-11 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-01-30 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2016-01-27 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2019-06-21 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-05-17 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2024-12-06 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-05-22 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-07-13 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2024-12-06 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-11-07 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2013-05-21 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2023-08-21 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-05-21 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2024-12-06 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2017-11-14 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2013-02-07 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2013-02-07 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Peripheral Blood Processing Device For Wound Management | PMQ | Class 2 | Hematology | No | 2026-05-29 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-05-20 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Prosthesis, Ankle, Uncemented, Non-Constrained | NTG | Class 3 | Unknown | No | 2013-02-07 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2013-05-22 |
| Spatula, Orthopedic | HXR | Class 1 | General, Plastic Surgery | No | 2013-12-02 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-05-21 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-05-22 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2013-05-22 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2026-02-27 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2013-01-31 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-12-02 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2021-04-08 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2018-11-21 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2016-01-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2026-01-26 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-12-02 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2013-02-07 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-02-06 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2013-05-22 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2013-05-22 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2026-05-29 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-05-22 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-05-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2013-05-21 |
| Prosthesis, Finger, Constrained, Metal/Polymer | KWG | Class 3 | Orthopedic | No | 2013-02-07 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-03-05 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2013-05-21 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2020-06-25 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-05-21 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-02-07 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2013-12-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-05-22 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-05-22 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-02-04 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2013-05-22 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2023-08-21 |
Proprietary Names
FusiFIX
Dental Implant System
STAGE - 1 Dental Implant System
SBI rHead Radial Head Extended System
Klassic HD® Femoral Stem, Porous
RingFIX, RAD Rozbruch Ankle Distraction
ROSA® Shoulder System
Pipeline Total Hip System
Block Stop Wires
rHead Plating System
STAGE-1 Dental Implant System
Silicone PIP
INSTRUMENT, SURGICAL, DISPOSABLE
rHead Lateral Assembly Radio
Manual Surgical Instrument, Multipl
CableFIX Xpress
ToeTac Xpress
PrimaConnex Dental Implant System
Knee Patella/Femoral
K-WIRES
knee femoral/tibial
AutoFIX
SBI TRIHEDRON MTP HEMI
A3 Anatomic Ankle Arthrodesis
Lite Bio Delivery System
STAR Scandinavian Total Ankle
Modular Tibia Tray
RESTORE Dental Implant System
SBI HAND FIXATION SY STEM
GDG / HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
Silicone MCP
EasyClip Xpress
Mini
PrimaSolo Dental Implant System
ATTUNE Medialized Anatomic Patella with AFFIXIUM 3DP Techology
ATTUNE Medialized Dome Patella with AFFIXIUM 3DP Techology
StaFIX
Precise SD Distal Radial Volar
Silicone TRL
MiniFix
SBI Mini Rail External Fixation System
FIBRINET (R) Autologous PRP System
Humerus Wires
SBI RADIO CAPITELLU
RENOVA Dental Implant System
TwistoFIX
AVANTA CMC
ARC Stem
PercuFIX
RingFIX Foot and Ankle Fixation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)