Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013156185

FEI Number

3013156185

Entity Name

MECTALENT LTD.

City/State/Country

Oulu Kainuu, FI

Establishment Address

Veistamotie 15, Oulu Kainuu FI-90620, FI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mectalent Ltd. (Owner Number: 10052131)

Owner / Operator Contact Address

Veistamotie 15, Oulu, FI-05 FI-90620, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Activa:RemeOs Inion Instrumentation ARTHROSCOPIC PISTON APPLICATOR PERCUTANEOUS TIP PERCUTANEOUS PISTON ARTHROSCOPIC TIP Inion Instrumentation Inion Instrumentation Inion ACL Instrumentation Inion Instrumentation Inion ACL Instrumentation Inion Instrumentation Inion Instrumentation K-Wire Inion Instrumentation Activa Instruments; RemeOs Instrument Handle Housing Inion Instrumentation Inion Instrumentation Inion Instrumentation Inion Instrumentation Activa Instrument; RemeOs Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2023-11-13
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-06-18
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2023-11-13
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-11-13
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2023-11-13
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-11-13
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-11-13
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-11-13
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2023-11-13
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2016-06-18
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2023-11-13
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-15
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2016-06-18
HXC	Wrench	Orthopedic	Class 1	888.4540	2023-11-13
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2023-11-13
HWJ	Awl	Orthopedic	Class 1	888.4540	2023-11-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-11-13

Official Correspondent

Pirkko Niemimaki

US Agent Details

Brent Lalomia Business: Conmed Corporation Email: brentlalomia@conmed.com Phone: (269) 3772187

Related Public Records

Same Entity

Mectalent Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013156185. Last updated year: 2026. Please use registration number 3013156185 when referencing this establishment in official correspondence.