Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010673777

FEI Number

3010673777

Entity Name

NOVASTEP

City/State/Country

RENNES Bretagne, FR

Establishment Address

2 allee Jacques Frimot, RENNES Bretagne 35000, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NOVASTEP (Owner Number: 10048280)

Owner / Operator Contact Address

2 allee Jacques Frimot, RENNES, FR-BRE 35000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Airlock Plating System Centrolock Guided Transverse Osteotomy System Novastep Orthopedic Manual Surgical Instrument Airlock® Ankle Plating System Arcad Staples; eXpress Staples Nexis Rearfoot Screws Novastep Guide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-08-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-12-17
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2014-12-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-04-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-04-03
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-12-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-11-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-05-25

Official Correspondent

Manon Dupleichs

US Agent Details

Vladislava Zaitseva Email: vladislava.zaitseva@enovis.com Phone: (706) 3465579

Related Public Records

Same Entity

NOVASTEP

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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

Similar Registrations

Registration Number	Establishment Name	Location
3013843055	BEIJING AK MEDICAL CO, LTD	Changping District Beijing, CN
3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3017609305	PRIMEMED INC.	Sungnam-city Gyeonggi, KR
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010673777. Last updated year: 2026. Please use registration number 3010673777 when referencing this establishment in official correspondence.