Coligne Ag

FDA Filings

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

FDA Registration(s)

• Registration Number: 1000493591
• FEI Number: 1000493591
• Name: David Luensmann
• Owner & Operator: COLIGNE AG
• Contact Address: UTOQUAI 43 --; ZURICH CH-ZH Zurich 8008 CH
• Official Correspondent:
  • ROBERT B LANGE
  • 41-43-3438000-x
• US Agent:
  • David Luensmann
  • New Road Enterprises, Inc
  • 303 4445972
  • david.young@coligne.com
• Importing Logistics Registration:
  • Importer: NEW ROAD ENTERPRISES, INC.
  • Address: 1951 33RD ST. ; Boulder, CO 80301 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1951 33rd St. ; Boulder, CO 80301 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07640173168737 coLigne AG	ostaPek Interbody Fusion Cage	2021-07-09
GUDID 07640173168720 coLigne AG	ostaPek Interbody Fusion Cage	2021-07-09
GUDID 07640173168713 coLigne AG	ostaPek Interbody Fusion Cage	2021-07-09
GUDID 07640173168706 coLigne AG	ostaPek Interbody Fusion Cage	2021-07-09
GUDID 07640173167150 coLigne AG	GII	2021-07-09
GUDID 07640173167143 coLigne AG	GII	2021-07-09
GUDID 07640173167136 coLigne AG	GII	2021-07-09
GUDID 07640173167129 coLigne AG	GII	2021-07-09
GUDID 07640173167112 coLigne AG	GII	2021-07-09
GUDID 07640173167105 coLigne AG	GII	2021-07-09
GUDID 07640173167099 coLigne AG	GII	2021-07-09
GUDID 07640173167082 coLigne AG	GII	2021-07-09
GUDID 07640173167075 coLigne AG	GII	2021-07-09
GUDID 07640173167068 coLigne AG	GII	2021-07-09
GUDID 07640173166436 coLigne AG	GII	2021-07-09
GUDID 07640173166429 coLigne AG	GII	2021-07-09
GUDID 07640173166412 coLigne AG	GII	2021-07-09
GUDID 07640173166405 coLigne AG	GII	2021-07-09
GUDID 07640173166399 coLigne AG	GII	2021-07-09
GUDID 07640173166382 coLigne AG	GII	2021-07-09
GUDID 07640173166320 coLigne AG	GII	2021-07-09
GUDID 07640173166313 coLigne AG	GII	2021-07-09
GUDID 07640173166306 coLigne AG	GII	2021-07-09
GUDID 07640173166290 coLigne AG	GII	2021-07-09
GUDID 07640173166108 coLigne AG	GII	2021-07-09
GUDID 07640173165620 coLigne AG	GII	2021-07-09
GUDID 07640173165569 coLigne AG	GII	2021-07-09
GUDID 07640173165422 coLigne AG	GII	2021-07-09
GUDID 07640173165415 coLigne AG	GII	2021-07-09
GUDID 07640173165408 coLigne AG	GII	2021-07-09
GUDID 07640173165392 coLigne AG	GII	2021-07-09
GUDID 07640173165385 coLigne AG	GII	2021-07-09
GUDID 07640173165378 coLigne AG	GII	2021-07-09
GUDID 07640173165361 coLigne AG	GII	2021-07-09
GUDID 07640173165354 coLigne AG	GII	2021-07-09
GUDID 07640173165347 coLigne AG	GII	2021-07-09
GUDID 07640173165330 coLigne AG	GII	2021-07-09
GUDID 07640173165323 coLigne AG	GII	2021-07-09
GUDID 07640173165316 coLigne AG	GII	2021-07-09
GUDID 07640173165309 coLigne AG	GII	2021-07-09
GUDID 07640173165293 coLigne AG	GII	2021-07-09
GUDID 07640173165286 coLigne AG	GII	2021-07-09
GUDID 07640173165279 coLigne AG	GII	2021-07-09
GUDID 07640173165262 coLigne AG	GII	2021-07-09
GUDID 07640173165255 coLigne AG	GII	2021-07-09
GUDID 07640173165248 coLigne AG	GII	2021-07-09
GUDID 07640173165231 coLigne AG	GII	2021-07-09
GUDID 07640173165224 coLigne AG	GII	2021-07-09
GUDID 07640173165217 coLigne AG	GII	2021-07-09
GUDID 07640173165200 coLigne AG	GII	2021-07-09
GUDID 07640173165194 coLigne AG	GII	2021-07-09
GUDID 07640173165187 coLigne AG	GII	2021-07-09
GUDID 07640173165170 coLigne AG	GII	2021-07-09
PMN K210306 Coligne AG	GII Spinal Fixation System	2021-05-19
GUDID 07640173167624 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167617 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167600 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167594 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167587 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167570 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167563 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167556 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167549 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167532 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167525 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167518 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167501 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167495 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167488 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167471 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167464 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167457 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167440 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167433 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167426 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167419 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167402 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167396 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167389 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167372 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167365 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167358 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167341 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167334 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167327 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167310 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167303 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167297 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167280 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167273 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167266 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167259 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167242 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167235 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167228 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167211 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167204 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167198 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167181 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167174 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
GUDID 07640173167167 coLigne AG	ostaPek Interbody Fusion Cage	2020-02-24
PMN K181963 | MAX David Luensmann [COLIGNE AG]	ostaPek Interbody Fusion Cages	2018-12-30
PMN K181963 CoLigne, AG	OstaPek Interbody Fusion Cages	2018-11-14
PMN K173893 | PLR David Luensmann [COLIGNE AG]	Trabis	2018-09-07
PMN K173893 CoLigne, AG	Trabis	2018-09-06
PMN K173148 | ODP David Luensmann [COLIGNE AG]	ACIF	2017-12-15
PMN K173148 CoLigne, AG	ACIF	2017-12-01
PMN K083567 | MNI David Luensmann [COLIGNE AG]	GII Spinal Fixation System	2009-09-28
PMN K083567 | MNH David Luensmann [COLIGNE AG]	GII Spinal Fixation System	2009-09-28
PMN K083567 | KWP David Luensmann [COLIGNE AG]	GII Spinal Fixation System	2009-09-28
PMN K072326 | MQP David Luensmann [COLIGNE AG]	OstaPek VBR System	2008-07-10
PMN K980852 | MNH David Luensmann [COLIGNE AG]	ostaPek	2008-01-17
PMN K980852 | MNH David Luensmann [COLIGNE AG]	GII	2008-01-17
PMN K051089 | MNI David Luensmann [COLIGNE AG]	ostaPek	2008-01-17
PMN K051089 | MNI David Luensmann [COLIGNE AG]	GII	2008-01-17
PMN K051089 | MNH David Luensmann [COLIGNE AG]	ostaPek	2008-01-17
PMN K051089 | MNH David Luensmann [COLIGNE AG]	GII	2008-01-17
PMN K051089 | KWP David Luensmann [COLIGNE AG]	ostaPek	2008-01-17
PMN K051089 | KWP David Luensmann [COLIGNE AG]	GII	2008-01-17
PMN K032604 | MNI David Luensmann [COLIGNE AG]	ostaPek	2008-01-17
PMN K032604 | MNI David Luensmann [COLIGNE AG]	GII	2008-01-17
PMN K032604 | MNH David Luensmann [COLIGNE AG]	ostaPek	2008-01-17
PMN K032604 | MNH David Luensmann [COLIGNE AG]	GII	2008-01-17
PMN K032604 | KWP David Luensmann [COLIGNE AG]	ostaPek	2008-01-17
PMN K032604 | KWP David Luensmann [COLIGNE AG]	GII	2008-01-17