Data / Medical devices / France / Implanet

Implanet: FDA-registered device maker in Martillac Nouvelle-Aquitaine, France, 21 510(k) clearances

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

Implanet is registered with the FDA (registration 3007675554) in Martillac Nouvelle-Aquitaine, France. It lists 14 device types. The FDA files 21 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007675554
Address: Technopole Bordeaux Montesquieu Allee Francois Magendie, Martillac Nouvelle-Aquitaine, France, 33650
Owner or operator: IMPLANET (10041401)
Roles: Manufacturer
First device listed: July 19, 2012
Registered through: 2026
Brand names listed: IMPLANET SPINE SYSTEM, IMPLANET SPINE SYSTEM (CALYPSO), Implanet Spine System, JAZZ, JAZZ FRAME, JAZZ LOCK, JAZZ SPINAL SYSTEM, JAZZ SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Bone Fixation Cerclage, Sublaminar	OWI	2	Manufacturer	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	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
February 26, 2026	K254017	SWINGO-3D Lumbar Cage System	MAX	Substantially Equivalent	Implanet	accessdata.fda.gov
August 28, 2025	K252437	JAZZ Spinal System	NKB	Substantially Equivalent	Implanet	accessdata.fda.gov
May 6, 2024	K240392	JAZZ Spinal System	NKB	Substantially Equivalent	Implanet	accessdata.fda.gov
March 28, 2023	K230026	SQUALE	ODP	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
April 6, 2020	K193494	Origin Anterior Cervical Plate System	KWQ	Substantially Equivalent	Orthopaedic & Spine Development	accessdata.fda.gov
October 22, 2019	K192084	Madison Total Knee System	JWH	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
August 2, 2019	K191217	JAZZ PF	OWI	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
March 12, 2019	K182771	ISS-JAZZ Screw System and JAZZ CAP SP	NKB	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
August 8, 2017	K171881	JAZZ Passer Band	OWI	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
June 9, 2017	K170730	JAZZ System, including JAZZ Band	OWI	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
January 19, 2017	K162764	JAZZ FRAME SYSTEM	NKB	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
May 18, 2016	K160226	JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector	NKB	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
March 31, 2016	K153348	JAZZ LOCK	OWI	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
August 27, 2015	K151740	JAZZ System	OWI	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
May 7, 2015	K143759	JAZZ System	OWI	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
April 14, 2015	K143731	IMPLANET Spine System (ISS)	NKB	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
February 20, 2014	K133617	JAZZ SYSTEM	OWI	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
October 10, 2013	K132303	IMPLANET SPINE SYSTEM	OSH	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
September 25, 2013	K132287	JAZZ SYSTEM	OWI	Substantially Equivalent	Hogan Lovells US LLP	accessdata.fda.gov
September 13, 2012	K121541	JAZZ SYSTEM	JDQ	Substantially Equivalent	Implanet, S.A.	accessdata.fda.gov
July 16, 2012	K120564	CALYPSO SYSTEM	NKB	Substantially Equivalent	Hogan Lovells US LLP	accessdata.fda.gov

Compare with other makers

Updated February 26, 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.