Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005144609

FEI Number

3005144609

Entity Name

EPTAM PLASTICS, LTD

City/State/Country

Northfield, NH, US

Establishment Address

2 Riverside Business Park, Northfield, NH 03276, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

EPTAM Plastics, Ltd (Owner Number: 10032547)

Owner / Operator Contact Address

2 Riverside Business Park, Northfield, NH 03276, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

4 Peg Mod Glen Trial Rt Aug 4 4 Peg Mod Glen Trial Lt Aug 2 4 Peg Mod Glen Trial Lt Aug 5 4 Peg Mod Glen Trial Rt Aug 3 4 Peg Mod Glen Trial Rt Aug 2 4 Peg Mod Glen Trial Lt Aug 3 4 Peg Mod Glen Trial Rt Aug 5 4 Peg Mod Glen Trial Lt Aug 4 4-Peg Aug Reamer Guide Right 4-Peg Aug Reamer Guide Left Wound Treatment System (VHT-200) Zimmer Persona Personalized Knee System Zimmer Persona Personalized Knee Medial Congruent Articular Surfaces POLY INSERT SIZE 4-3 15MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 13MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 14MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-3 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-3 11MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-3 17MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 6MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 16MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 15MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 16MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 6MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-3 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 12MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 16MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 16MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-3 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 12MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 16MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 10MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-3 13MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 12MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 14MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 17MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 6MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 14MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 12MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-2 6MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-2 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 12MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 14MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 6MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 2-1 9MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 12MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 14MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 6MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-4 11MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-4 14MM INCOMPASS TOTAL ANKLE SYSTEM ROTATION GUIDE SLIDER INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 5-5 7MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 4-3 8MM INCOMPASS TOTAL ANKLE SYSTEM POLY INSERT SIZE 3-3 16MM INCOMPASS TOTAL ANKLE SYSTEM Zimmer Biomet ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS Alliance Glenoid TRAY / ART SURF INSERTER TIP FLEX / EXT GAP SPACER 14MM DISPOSABLE OFS HEAD SEATER CAP FLEX / EXT GAP SPACER 12MM FLEX / EXT GAP SPACER 8MM FLEX / EXT GAP SPACER 10MM Zimmer Biomet TIBIAL SPACER GUIDE SZ 3 INCOMPASS TOTAL ANKLE SYSTEM TIBIAL SPACER GUIDE SZ 4 INCOMPASS TOTAL ANKLE SYSTEM TIBIAL SPACER GUIDE SZ 2 INCOMPASS TOTAL ANKLE SYSTEM TIBIAL SPACER GUIDE SZ 5 INCOMPASS TOTAL ANKLE SYSTEM TALAR DOME PROTECTOR SZ 5 INCOMPASS TOTAL ANKLE SYSTEM TALAR DOME PROTECTOR SZ 2 INCOMPASS TOTAL ANKLE SYSTEM TALAR DOME PROTECTOR SZ 4 INCOMPASS TOTAL ANKLE SYSTEM LINER HEAD PRESS GUARD TALAR DOME PROTECTOR SZ 3 INCOMPASS TOTAL ANKLE SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-02-26
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-02-25
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2020-02-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-02-26
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2013-02-26
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2025-08-01
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-10-22
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2013-02-26
NQP	Posterior Metal/Polymer Spinal System, Fusion	Orthopedic	Class 2	888.3070	2013-02-26
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2018-07-11
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2018-07-11
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2018-07-11
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2025-08-05
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-09-22
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2016-03-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2016-03-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-03-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-02-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2016-03-18
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2014-01-31
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2015-01-05
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2021-09-22
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2019-12-05
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-12-05
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2013-02-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2013-02-26
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-01-19

Official Correspondent

William Sorensen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EPTAM Plastics, Ltd

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
K032752	R&B Surgical Solutions, LLC	R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM	2003-12-03
K062643	Life Spine	KINETIC ANTERIOR CERVICAL PLATE	2006-11-16
K904879	Endotec, Inc.	BEUCHEL-PAPPAS GLENOID COMPONENT	1991-01-28
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013	Medtronic Sofamor Danek USA Inc	2	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013	Medtronic Sofamor Danek USA Inc	2	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05	Zimmer Spine, Inc.	2	ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005144609. Last updated year: 2026. Please use registration number 3005144609 when referencing this establishment in official correspondence.