Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015780293

FEI Number

3015780293

Entity Name

ARCTIC BIOMATERIALS OY

City/State/Country

Tampere Pirkanmaa, FI

Establishment Address

Arvo Ylpon katu 41, Tampere Pirkanmaa 33520, FI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Arctic Biomaterials Oy (Owner Number: 10062418)

Owner / Operator Contact Address

Arvo Ylpon katu 41, Tampere, FI-11 33520, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-24
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Orthopedic	Class 2	888.3060	2022-09-09
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2022-02-07
JEY	Plate, Bone	Dental	Class 2	872.4760	2022-05-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-06-30
JEY	Plate, Bone	Dental	Class 2	872.4760	2021-06-30
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-02-07
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2022-09-09
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Orthopedic	Class 2	888.3060	2022-09-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-24
JEY	Plate, Bone	Dental	Class 2	872.4760	2021-06-30
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-02-07
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2020-01-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-09-09
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-02-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-30
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate	Orthopedic	Class 2	888.3060	2022-09-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-30
JEY	Plate, Bone	Dental	Class 2	872.4760	2022-05-17
JEY	Plate, Bone	Dental	Class 2	872.4760	2022-05-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2020-08-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-06-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-06-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-08-21

Official Correspondent

Sanna Ritala

US Agent Details

Elaine Duncan Business: Paladin Medical Inc Email: duncan@paladinmedical.com Phone: (715) 5496035

Related Public Records

Same Entity

Arctic Biomaterials Oy

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015780293. Last updated year: 2026. Please use registration number 3015780293 when referencing this establishment in official correspondence.