FIVE STAR MANUFACTURING, INC.

FDA Device Registration & Listing · NEW BEDFORD, MA, US · Registration 3004513872

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
3004513872
FEI Number
3004513872
Entity Name
FIVE STAR MANUFACTURING, INC.
City/State/Country
NEW BEDFORD, MA, US
Establishment Address
163 SAMUEL BARNET BLVD., NEW BEDFORD, MA 02745, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
FIVE STAR MANUFACTURING, INC. (Owner Number: 9061981)
Owner / Operator Contact Address
163 SAMUEL BARNET BLVD., --, New Bedford, MA 02745, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM COONRAD MORREY ELBOW WITH HINGE PIN BASE NO. 8105, 8106 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXL Mallet General, Plastic Surgery Class 1 878.4800 2019-07-08
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-03-08
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-03-08
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2021-08-27
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-03-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-03-14
HTR Rasp General, Plastic Surgery Class 1 878.4800 2018-08-23
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2020-09-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2020-09-25
HWT Template Orthopedic Class 1 888.4800 2022-01-07
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-03-14
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2013-03-14
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2013-03-14
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-03-14
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-03-14
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2013-03-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-03-14
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2013-03-14
GAD Retractor General, Plastic Surgery Class 1 878.4800 2022-06-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2019-07-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-03-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-03-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-03-14
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-08-23
FSP Loupe, Diagnostic/Surgical General, Plastic Surgery Class 1 878.4800 2007-04-18
HWJ Awl Orthopedic Class 1 888.4540 2018-08-23
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2019-01-29
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2021-02-18
HXW Bender Orthopedic Class 1 888.4540 2020-09-22
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2019-01-29
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2023-06-20
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2018-08-23
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-03-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-03-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-03-14

Official Correspondent

DAVID CABRAL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FIVE STAR MANUFACTURING, INC.
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
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K010427 Walter Lorenz Surgical, Inc. LORENZ FIDUCAIL SCREW 2001-03-15
K812744 Progress Mankind Technology LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER 1981-12-03
K092467 Brainlab AG VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED 2010-05-06
K031454 Biomet, Inc. ACUMEN SURGICAL NAVIGATION SYSTEM 2004-07-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-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.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, 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.
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004513872. Last updated year: 2026. Please use registration number 3004513872 when referencing this establishment in official correspondence.
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