Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222928

FEI Number

1000120613

Entity Name

Primo Medical Group, INC

City/State/Country

STOUGHTON, MA, US

Establishment Address

75 Mill St, STOUGHTON, MA 02072, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Primo Medical Group, Inc (Owner Number: 9004401)

Owner / Operator Contact Address

75 Mill Street, Stoughton, MA 02072, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Preformed Anchor Scan abutment Bone Tap Awl Engage Surgical Pins STD MED Primo Port Poly Vesiflo inFlow urinary prosthesis Instrument Guide ENDOFLO SUCTION IRRIGATION PROBE DISP. LAPAROSCOPIC SCISSORS W ELECTRO SURGICAL FOOT SWITCH PRIMO PORT Drill Bit Caddy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2013-01-30
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2013-01-30
EJX	Anchor, Preformed	Dental	Class 1	872.3130	2013-12-17
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2013-12-17
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-11-18
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-01-30
OQL	Mesh, Surgical, Deployment Balloon	General, Plastic Surgery	Class 2	878.3300	2013-01-30
HWJ	Awl	Orthopedic	Class 1	888.4540	2013-11-18
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2025-11-20
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-01-30
OQL	Mesh, Surgical, Deployment Balloon	General, Plastic Surgery	Class 2	878.3300	2013-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2013-01-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-11-06
NJD	Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	Orthopedic	Class 2	888.3535	2020-11-06
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2013-03-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2023-09-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-09-23
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-30
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2018-08-02
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2018-08-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-08-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-11-06
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-09-02
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2009-12-04
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-09-02
PIH	Urethral Insert With Pump For Bladder Drainage	Gastroenterology, Urology	Class 2	876.5140	2018-09-07
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-30
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2013-01-30
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2013-01-30
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-08-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-23
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-06-11
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-11-18
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-08-19
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2020-04-27
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2015-07-30
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-01-24
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-05-30
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2013-01-30
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2025-09-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-27
HXG	Tamp	Orthopedic	Class 1	888.4540	2024-08-19
HBI	Illuminator, Fiberoptic, Surgical Field	General, Plastic Surgery	Class 2	878.4580	2019-09-23
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2019-09-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-09-23
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2019-09-23
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2019-09-23
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	1992-08-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-11-20
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-01-30
MZY	Graft, Vascular, Stainless Steel Tunneler	Cardiovascular	Class 2	870.3450	2016-02-10
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1992-08-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-09-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-08-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2019-08-22
QPB	System, Suction, Lipoplasty For Removal	General, Plastic Surgery	Class 2	878.5040	2015-07-30
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-18
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2013-01-30
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	Class 2	888.3400	2013-01-30
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-11-18
LTI	Implant, Intragastric For Morbid Obesity	Unknown	Class 3	N/A	2015-11-06
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2021-05-17
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2013-06-11
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-03-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Primo Medical Group, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009420598	Primo Medical Group, Inc	W Bridgewater, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
K984202	Howmedica, Inc.	HOWMEDICA HUMERAL INTERCALARY SYSTEM	1999-02-05
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222928. Last updated year: 2026. Please use registration number 1222928 when referencing this establishment in official correspondence.