Clariance S A S

FDA Filings

This page includes the latest FDA filings for Clariance S A S. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009962553
• FEI Number: 3009962553
• Name: Clariance, Inc.
• Owner & Operator: CLARIANCE-SAS
• Contact Address: 18, rue Robespierre ; BEAURAINS FR-O Nord-Pas-de-Calais 62217 FR
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4809 N. RAVENSWOOD AVENUE, SUITE119 ; Chicago, IL 60640 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Device in the United States for Export Only
  • Repack or Relabel Medical Device

• Registration Number: 3008992889
• FEI Number: 3008992889
• Name: CLARIANCE-SAS
• Owner & Operator: CLARIANCE-SAS
• Contact Address: 18, rue Robespierre ; BEAURAINS FR-O Nord-Pas-de-Calais 62217 FR
• US Agent:
  • Sylvain Chambat
  • Clariance, Inc.
  • 773 8687041
  • 773 8687043
  • s.chambat@clariance-spine.us
• Importing Logistics Registration:
  • Importer: Clariance, Inc.
  • Address: 4001 Ravenswood Avenue Unit 3 -3-C ; Chicago, IL 60613 UNITED STATES
  • Email Address: s.chambat@clariance-spine.us
  • Phone: 1 678 7352098
  • Importer Type: Initial Importer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 18, rue Robespierre ; BEAURAINS Nord-Pas-de-Calais, 62217 FR
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K202032 Clariance, SAS	Idys LLIF 3DTi	2021-04-01
PMN K202956 Clariance, SAS	Erisma LP Navigated Instruments	2021-02-26
PMN K200920 Clariance, SAS	Idys ALIF ZP 3DTi	2020-05-29
PMN K192168 | OVD Clariance, Inc. [CLARIANCE-SAS]	Idys? ALIF ZP 3DTi	2019-12-26
PMN K192168 | OVD CLARIANCE-SAS	Idys? ALIF ZP 3DTi	2019-12-26
PMN K192168 CLARIANCE, SAS	Idys ALIF ZP 3DTi	2019-11-04
PMN K191263 | OVD Clariance, Inc. [CLARIANCE-SAS]	Idys? ALIF TiVac	2019-07-01
PMN K191263 | OVD CLARIANCE-SAS	Idys? ALIF TiVac	2019-07-01
PMN K191263 Clariance SAS	Idys ALIF TiVac	2019-06-06
PMN K183259 | MAX Clariance, Inc. [CLARIANCE-SAS]	Idys TLIF TiVac	2019-03-04
PMN K183259 | MAX CLARIANCE-SAS	Idys TLIF TiVac	2019-03-04
PMN K183259 Clariance SAS	Idys™ TLIF TiVac	2019-03-01
HXB Clariance, Inc. [CLARIANCE-SAS]	spinal instruments	2018-10-24
HWR Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-06-07
HWR CLARIANCE-SAS	Idys-ALIF	2018-06-07
HTF Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-06-07
HTF CLARIANCE-SAS	Idys-ALIF	2018-06-07
HTX Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-05-24
HTX CLARIANCE-SAS	Idys-ALIF	2018-05-24
HTJ Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-05-24
HTJ CLARIANCE-SAS	Idys-ALIF	2018-05-24
HTE Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-05-24
HTE CLARIANCE-SAS	Idys-ALIF	2018-05-24
HTD Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-05-24
HTD CLARIANCE-SAS	Idys-ALIF	2018-05-24
GAD Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-05-24
GAD CLARIANCE-SAS	Idys-ALIF	2018-05-24
FZO Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-05-24
FZO CLARIANCE-SAS	Idys-ALIF	2018-05-24
PMN K170163 | NKB Clariance, Inc. [CLARIANCE-SAS]	Erisma-LP	2018-03-30
PMN K170163 | NKB CLARIANCE-SAS	Erisma-LP	2018-03-30
LXH Clariance, Inc. [CLARIANCE-SAS]	SPINAL INSTRUMENTS	2018-03-29
LXH Clariance, Inc. [CLARIANCE-SAS]	Idys-LIF	2018-03-29
LXH Clariance, Inc. [CLARIANCE-SAS]	Idys-ALIF	2018-03-29
LXH CLARIANCE-SAS	SPINAL INSTRUMENTS	2018-03-29
LXH CLARIANCE-SAS	Idys-LIF	2018-03-29
LXH CLARIANCE-SAS	Idys-ALIF	2018-03-29
PMN K172465 | MAX Clariance, Inc. [CLARIANCE-SAS]	Idys? TLIF 3DTi	2017-12-27
PMN K172465 | MAX CLARIANCE-SAS	Idys? TLIF 3DTi	2017-12-27
PMN K172083 | OVD Clariance, Inc. [CLARIANCE-SAS]	Idys?-ALIF	2017-12-27
PMN K172083 | OVD CLARIANCE-SAS	Idys?-ALIF	2017-12-27
PMN K172465 CLARIANCE, SAS	Idys™ TLIF 3DTi Cages	2017-12-15
PMN K172083 CLARIANCE SAS	Idys™ ALIF System	2017-11-08
PMN K170163 CLARIANCE SAS	Erisma® LP Spinal Fixation System	2017-02-14
PMN K162367 | NKB Clariance, Inc. [CLARIANCE-SAS]	ERISMA LP MIS	2016-11-15
PMN K162367 | NKB CLARIANCE-SAS	ERISMA LP MIS	2016-11-15
PMN K162367 | MNI Clariance, Inc. [CLARIANCE-SAS]	ERISMA LP MIS	2016-11-15
PMN K162367 | MNI CLARIANCE-SAS	ERISMA LP MIS	2016-11-15
PMN K162367 | MNH Clariance, Inc. [CLARIANCE-SAS]	ERISMA LP MIS	2016-11-15
PMN K162367 | MNH CLARIANCE-SAS	ERISMA LP MIS	2016-11-15
PMN K162367 CLARIANCE SAS	Erisma® LP MIS	2016-10-27
PMN K153326 | NKB Clariance, Inc. [CLARIANCE-SAS]	Erisma-LP	2016-03-24
PMN K153326 | NKB CLARIANCE-SAS	Erisma-LP	2016-03-24
PMN K153326 | MNI Clariance, Inc. [CLARIANCE-SAS]	Erisma-LP	2016-03-24
PMN K153326 | MNI CLARIANCE-SAS	Erisma-LP	2016-03-24
PMN K153326 | MNH Clariance, Inc. [CLARIANCE-SAS]	Erisma-LP	2016-03-24
PMN K153326 | MNH CLARIANCE-SAS	Erisma-LP	2016-03-24
PMN K153326 CLARIANCE, SAS	Erisma-LP Spinal Fixation System	2016-03-08
PMN K130853 | ODP Clariance, Inc. [CLARIANCE-SAS]	Idys-C	2013-11-25
PMN K130853 | ODP CLARIANCE-SAS	Idys-C	2013-11-25
PMN K131178 | MAX Clariance, Inc. [CLARIANCE-SAS]	Idys TLIF	2013-10-31
PMN K131178 | MAX Clariance, Inc. [CLARIANCE-SAS]	Idys PTLIF	2013-10-31
PMN K131178 | MAX Clariance, Inc. [CLARIANCE-SAS]	Idys PLIF	2013-10-31
PMN K131178 | MAX CLARIANCE-SAS	Idys TLIF	2013-10-31
PMN K131178 | MAX CLARIANCE-SAS	Idys PTLIF	2013-10-31
PMN K131178 | MAX CLARIANCE-SAS	Idys PLIF	2013-10-31
PMN K120469 | NKB Clariance, Inc. [CLARIANCE-SAS]	Erisma-LP	2013-03-13
PMN K120469 | NKB CLARIANCE-SAS	Erisma-LP	2013-03-13
PMN K120469 | MNI Clariance, Inc. [CLARIANCE-SAS]	Erisma-LP	2013-03-13
PMN K120469 | MNI CLARIANCE-SAS	Erisma-LP	2013-03-13
PMN K120469 | MNH Clariance, Inc. [CLARIANCE-SAS]	Erisma-LP	2013-03-13
PMN K120469 | MNH CLARIANCE-SAS	Erisma-LP	2013-03-13