Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015679904

FEI Number

3015679904

Entity Name

OTN Implants B.V.

City/State/Country

Nijmegen Gelderland, NL

Establishment Address

Griftdijk 105, Nijmegen Gelderland 6515 AE, NL

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

OTN Implants B.V. (Owner Number: 10061094)

Owner / Operator Contact Address

Simon Stevinweg 48, Arnhem, NL-GE 6827BT, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OTNI CR01 OTNI CR02 OTNI RR02 OTNI RR01 OTNI RR03

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTQ	Broach	Orthopedic	Class 1	888.4540	2019-08-16
HTO	Reamer	Orthopedic	Class 1	888.4540	2019-08-16
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2019-08-16

Official Correspondent

Pamela Musch

US Agent Details

Glenn Choi Business: ST&G USA CORP. Email: info@stngco.com Phone: (714) 5240663

Related Public Records

Same Entity

OTN Implants B.V.

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015679904. Last updated year: 2026. Please use registration number 3015679904 when referencing this establishment in official correspondence.