Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005536892

FEI Number

3005536892

Entity Name

Bioretec Ltd.

City/State/Country

Tampere Pirkanmaa, FI

Establishment Address

Yrittajankulma 5, Tampere Pirkanmaa FI-33710, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bioretec Ltd. (Owner Number: 9093133)

Owner / Operator Contact Address

Yrittajankulma 5, Tampere, FI-NOTA FI-33710, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Activa RemeOs RemeOs Screw LAG Solid ActivaScrew Interference RemeOs Instrument Activa Instrument RemeOs Instruments Activa Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2008-01-02
QJD	Absorbable Metallic Bone Fixation Fastener	Orthopedic	Class 2	888.3041	2023-04-12
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-09-12
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-01-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2008-01-02

Official Correspondent

Mari Ruotsalainen

US Agent Details

Edwin Lindsay Business: RAF Solutions Inc. Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

Bioretec 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
K203334	Acuitive Technologies, Inc.	The Citrefix Knotless Suture Anchor	2021-02-05
K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	2024-12-03
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3019356409	INTELIVATION TECHNOLOGIES, LLC	Plymouth Meeting, PA, US
3004641308	ENZTEC LIMITED	CHRISTCHURCH Canterbury, NZ
3016112537	MAINSTREAM MEDICAL DEVICES	Austin, TX, US
1645151	CENTEX MACHINING, INC.	Round Rock, TX, US
9612420	ULRICH GMBH & CO. KG	ULM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005536892. Last updated year: 2026. Please use registration number 3005536892 when referencing this establishment in official correspondence.