Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011874600

FEI Number

3011874600

Entity Name

MEDICAL COMPONENT SPECIALISTS

City/State/Country

Bellingham, MA, US

Establishment Address

42 Williams Way, Bellingham, MA 02019, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medical Component Specialists (Owner Number: 10053311)

Owner / Operator Contact Address

42 Williams way, Bellingham, MA 02019, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Accelus DJO Alctus Spine Pedicle Screw System Accelus Sniper Staple DJO Sniper Staple

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2022-04-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-03-11
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-11-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-11-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2016-11-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-11-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-11-21
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-04-13
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-30
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-03-11
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-06
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2021-07-27

Official Correspondent

Kevin Rebello

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medical Component Specialists

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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

Registration Number	Establishment Name	Location
3017836103	KYIN MANUFACTURING, LLC	Louisville, KY, US
1226544	MILLSTONE MEDICAL OUTSOURCING LLC.	FALL RIVER, MA, US
1825034	BIOMET, INC.	WARSAW, IN, US
8043862	AAP IMPLANTATE AG	BERLIN, DE
1221763	ARCH Medical Solutions - Seabrook	SEABROOK, NH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011874600. Last updated year: 2026. Please use registration number 3011874600 when referencing this establishment in official correspondence.