Data / Medical devices / France / Novastep

Novastep: FDA-registered device maker in RENNES Bretagne, France, 10 510(k) clearances

Name: Novastep FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Novastep is registered with the FDA (registration 3010673777) in RENNES Bretagne, France. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 25, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Novastep

FDA registration number: 3010673777
Address: 2 allee Jacques Frimot, RENNES Bretagne, France, 35000
Owner or operator: NOVASTEP (10048280)
Roles: Manufacturer
First device listed: December 23, 2014
Registered through: 2026
Brand names listed: Airlock Plating System, Airlock® Ankle Plating System, Arcad Staples; eXpress Staples, Centrolock Guided Transverse Osteotomy System, Lync Hammertoe Correction System, Nexis Cannulated Screws, Nexis Rearfoot Screws, Nexis Snap-Off Screws and more

Devices it lists

Device	Product code	Class	Role	Source
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 25, 2026	K260274	Airlock® Ankle Plating System	HRS	Substantially Equivalent	Novastep SAS	accessdata.fda.gov
December 4, 2023	K230724	arcad® 2.0 Duo & Quadro osteosynthesis compressive staples	JDR	Substantially Equivalent	Novastep	accessdata.fda.gov
August 30, 2023	K223468	Nexis® compressive screws	HWC	Substantially Equivalent	Novastep	accessdata.fda.gov
December 14, 2019	K192356	Airlock Centrolock Osteosynthesis Implant System	HRS	Substantially Equivalent	Novastep	accessdata.fda.gov
August 13, 2015	K151277	Airlock® osteosynthesis plate system	HRS	Substantially Equivalent	Novastep	accessdata.fda.gov
April 6, 2015	K143523	Airlock osteosynthesis plate system	HRS	Substantially Equivalent	Novastep	accessdata.fda.gov
February 19, 2015	K143049	LYNC intramedullary implant	HTY	Substantially Equivalent	Novastep	accessdata.fda.gov
February 6, 2015	K143229	Nexis osteosynthesis compressive screws	HWC	Substantially Equivalent	Novastep	accessdata.fda.gov
February 6, 2015	K143146	Nexis osteosynthesis snap-off screws	HWC	Substantially Equivalent	Novastep	accessdata.fda.gov
December 19, 2014	K142111	ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE	JDR	Substantially Equivalent	Novatsep	accessdata.fda.gov

Compare with other makers

Updated March 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.