Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007675554

FEI Number

3007675554

Entity Name

IMPLANET

City/State/Country

Martillac Nouvelle-Aquitaine, FR

Establishment Address

Technopole Bordeaux Montesquieu, Allee Francois Magendie, Martillac Nouvelle-Aquitaine 33650, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMPLANET (Owner Number: 10041401)

Owner / Operator Contact Address

Technopole Bordeaux Montesquieu, Allee Francois Magendie, Martillac, FR-NAQ 33650, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193494

PMA Number

N/A

All Registered Proprietary Names

MADISON Total Knee System IMPLANET SPINE SYSTEM (CALYPSO) IMPLANET SPINE SYSTEM JAZZ Systems JAZZ System SWINGO-3D IMPLANET SPINE SYSTEM (CALYPSO) JAZZ System JAZZ FRAME JAZZ SPINAL SYSTEM JAZZ JAZZ LOCK JAZZ System JAZZ SPINAL SYSTEM Implanet Spine System SQUALE JAZZ JAZZ System JAZZ System JAZZ JAZZ System ORIGIN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-12-06
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-07-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-07-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-07-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-07-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-10-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-10-28
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2013-10-28
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-10-28
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-10-28
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2019-08-28
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2013-10-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-03-05
HWT	Template	Orthopedic	Class 1	888.4800	2012-09-13
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2014-04-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-01-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-09-26
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2017-09-01
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2016-04-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2016-05-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2016-05-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2016-05-19
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2016-05-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2016-05-19
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2016-05-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-07-24
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-07-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-07-03
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2015-07-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-07-03
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-07-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-05-05
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2017-06-12
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-03-14
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2015-07-02
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2015-09-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-06-07

Official Correspondent

Regis LE COUEDIC

US Agent Details

Shane Doyle Business: Implanet America Inc Email: reglementaire@implanet.com Phone: (855) 4444675

Related Public Records

Same Entity

IMPLANET

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
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17
K102380	Wrightmedicaltechnologyinc	EVOLUTION MP TOTAL KNEE SYSTEM	2011-01-07
K122985	Aesculap Implant System, Inc.	COLUMBUS REVISION KNEE SYSTEM	2012-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06	Plus Orthopedics USA	2	TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007675554. Last updated year: 2026. Please use registration number 3007675554 when referencing this establishment in official correspondence.