FDA Registration
Active
🇺🇸 United States
FIVE STAR MANUFACTURING, INC.
Reg #: 3004513872
·
FEI: 3004513872
·
Expires 2026
Products
41
Proprietary Names
45
Establishment Types
3
Classifications
41
Registration Details
- Registration Name
- FIVE STAR MANUFACTURING, INC.
- Registration Number
- 3004513872
- FEI Number
- 3004513872
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 163 SAMUEL BARNET BLVD.
- City
- NEW BEDFORD
- State
- MA
- ZIP
- 02745
- Country
- US
Owner / Operator
- Firm Name
- FIVE STAR MANUFACTURING, INC.
- Operator Number
- 9061981
- Address
- 163 SAMUEL BARNET BLVD., --
- City
- New Bedford
- State
- MA
- Postal Code
- 02745
- Country
- US
- Correspondent
- DAVID A CABRAL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2019-07-08 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2019-03-08 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2019-03-08 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2021-08-27 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2013-03-14 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2018-08-23 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2020-09-25 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-09-25 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-01-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2013-03-14 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-03-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-06-28 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-07-08 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2013-03-14 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-08-23 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2007-04-18 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2018-08-23 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2019-01-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2021-02-18 |
| Bender | HXW | Class 1 | Orthopedic | No | 2020-09-22 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2019-01-29 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2023-06-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-08-23 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-03-08 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2021-08-27 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-09-22 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-09-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-31 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2024-01-09 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-01-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-08-23 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2016-08-30 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2021-08-27 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2022-01-07 |
Proprietary Names
ZNN Slotted Mallet
STEREOTAXIC INSTRUMENTS
Guide Wire Gripper, Guide Wire Pusher
Prosthesis
COONRAD MORREY ELBOW WITH HINGE PIN BASE NO. 8105, 8106
Transfx external fixation system protective caps 3.5mm to 4mm pins
Transfx external fixation system protective caps 4.5mm to 5mm pins
Adjustable Double Pin Guide
MG Unicondylar Provisional
Semi-constrained
Top Hip Instrumentation Blade Large
Top Hip Instrumentation Blade Small
Total Hip Instrumentation
RF Screw Depth Gage 8MM
Non-constrained
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
Wrench
Hand Retractor
Drill Guide 4.5 mm
Drill Guide 3 mm
Insert 2.5 for 4.3 Cannula
Guide Compression Drill for 5 Screws
Drill Guide 3.5 mm
Zimmer Trabecular Metal Total Ankle
Blade, Carpal Tunnel Release
BIGLIANI/FLATOW SHOULDER STRAIGHT DRIVER BASE NO. 4301
Shoulder
NEXGEN COMPLETE KNEE SOLUTION TIBIAL BOOM 7 DEGREE
Zimmer Natural Nail System
Greater Trochanter Femoral Nail
Piriformis Fossa Femoral Nail
Slaphammer
Cannula Screw 95 Deg
Ortho
Lg Screw Dpth Guage 8mm, Lg Cann screw dpth guage, Short screw dpth guage 8mm
Slaphammer, Reduction Finger, Nail Length Gauge, Entry Cann Starting Pt Loctr,, Impaction head, Lg Screw Trocar 8mm,
Freehand Targeting dpth guage, freehand tissue protec sleeve, Nail cap insrtr, nail cap ret sft
M/DN INTRAMEDULLARY FIXATION SYSTEM
AR-3714 Knee FiberTak Punch, 2.6mm
11mm Hex / Pin Wrench
NEXGEN INTRAMEDULLARY INSTRUMENTS BASE NO 5967, 5968
Retractor
Cephalomedullary Extraction Rod - M!! Thread
Entry Cannula
NGK Tibial Instruments
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device