Safe Orthopaedics

FDA Filings

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

FRANCE

EURONEXT PARIS

ALSAF

DUNS 261875917

FDA Registration(s)

• Registration Number: 3009509485
• FEI Number: 3009509485
• Name: David Lennarz
• Owner & Operator: Safe Orthopaedics
• Contact Address: BATIMENT LE CALIFORNIE PARC DES BEL ; ERAGNY SUR OISE FR-95 Val-dOise 95610 FR
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 144 Research Drive ; Hampton, VA 23666 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3009761545
• FEI Number: 3009761545
• Name: Safe Orthopaedics, LLC
• Owner & Operator: Safe Orthopaedics
• Contact Address: BATIMENT LE CALIFORNIE PARC DES BEL ; ERAGNY SUR OISE FR-95 Val-dOise 95610 FR
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1700 W Irving Park Rd Suite 303; Chicago, IL 60613 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 03760219919803 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219919797 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219919780 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219919766 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916857 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916840 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916826 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916819 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916802 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916796 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916789 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916765 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916758 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916741 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916734 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916727 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916710 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916703 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916680 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916673 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916666 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916659 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916642 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916635 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916628 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916611 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916604 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219916598 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913603 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913597 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913580 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913573 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913559 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913542 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913535 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913443 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913436 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913429 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913412 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913337 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913313 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913306 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913290 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913283 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913276 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913269 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913252 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913245 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913238 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913221 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913214 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913207 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219913191 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910336 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910329 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910312 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910299 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910275 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910268 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910251 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910244 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910237 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910220 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910213 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910206 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910190 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910015 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219910008 SAFE ORTHOPAEDICS	STERISPINE PS	2020-10-09
GUDID 03760219919773 SAFE ORTHOPAEDICS	STERISPINE PS	2020-09-09
GUDID 03760219916833 SAFE ORTHOPAEDICS	STERISPINE PS	2020-09-09
GUDID 03760219916581 SAFE ORTHOPAEDICS	STERISPINE PS	2020-09-09
GUDID 03760219913610 SAFE ORTHOPAEDICS	STERISPINE PS	2020-09-09
PMN K201648 Safe Orthopaedics	Sterispine™ PS	2020-07-30
GUDID 03760219913870 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-10
GUDID 03760219913351 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-10
GUDID 03760219911159 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910978 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910817 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910800 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910794 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910787 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910770 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910756 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910725 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910718 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910688 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910640 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910596 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910589 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910572 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910558 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910534 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910527 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910510 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910503 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910480 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910473 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910466 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910459 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910442 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
GUDID 03760219910435 SAFE ORTHOPAEDICS	STERISPINE PS	2020-07-06
HXB David Lennarz [Safe Orthopaedics]	Sterispine PS: Thoracolumbosacral pedicle screw system (PSANC068: Spatula for diam 4.5mm screws)	2017-04-25
PMN K170528 SAFE ORTHOPAEDICS	Sterispine™ PS	2017-03-09
PMN K170528 | NKB David Lennarz [Safe Orthopaedics]	Sterispine PS	2017-03-09
PMN K162531 | OVE David Lennarz [Safe Orthopaedics]	Sterispine CC: Intervertebral body fusion device	2017-01-03
PMN K162531 SAFE ORTHOPAEDICS	STERISPINE CC	2016-12-29
PMN K151921 | NKB David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151921 | MNI David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151921 | MNH David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151921 | KWP David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151747 | NKB David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151747 | MNI David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151747 | MNH David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151747 | KWP David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2015-10-19
PMN K151921 SAFE ORTHOPAEDICS	STERISPINE PS	2015-10-08
PMN K151747 SAFE ORTHOPAEDICS	STERISPINE PS	2015-10-05
PMN K151756 | MAX David Lennarz [Safe Orthopaedics]	SteriSpineLC -Intervertebral body fusion device	2015-09-14
PMN K151756 SAFE ORTHOPAEDICS	STERISPINE LC CAGE	2015-08-21
PMN K150092 | NKB David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2015-04-24
PMN K150092 | NKB David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2015-04-24
PMN K150092 | NKB David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2015-04-24
PMN K150092 | MNI David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2015-04-24
PMN K150092 | MNI David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2015-04-24
PMN K150092 | MNI David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2015-04-24
PMN K150092 | MNH David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2015-04-24
PMN K150092 | MNH David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2015-04-24
PMN K150092 | MNH David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2015-04-24
PMN K150092 | KWP David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2015-04-24
PMN K150092 | KWP David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2015-04-24
PMN K150092 | KWP David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2015-04-24
PMN K150092 SAFE ORTHOPAEDICS	STERISPINE PS Pedicle Screw	2015-02-10
PMN K140802 | NKB David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2014-06-23
PMN K140802 | NKB David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2014-06-23
PMN K140802 | NKB David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2014-06-23
PMN K140802 | MNI David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2014-06-23
PMN K140802 | MNI David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2014-06-23
PMN K140802 | MNI David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2014-06-23
PMN K140802 | MNH David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2014-06-23
PMN K140802 | MNH David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2014-06-23
PMN K140802 | MNH David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2014-06-23
PMN K140802 | KWP David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2014-06-23
PMN K140802 | KWP David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2014-06-23
PMN K140802 | KWP David Lennarz [Safe Orthopaedics]	PSANC026, PSANC027, SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2014-06-23
PMN K140802 SAFE ORTHOPAEDICS	STERISPINE PS	2014-06-04
HWN David Lennarz [Safe Orthopaedics]	SteriSpinePS - Pedicle screw spinal system	2014-04-02
PMN K133893 | MAX Safe Orthopaedics, LLC [Safe Orthopaedics]	SteriSpineLC - Lumbar Cage System	2014-03-20
PMN K133893 | MAX David Lennarz [Safe Orthopaedics]	SteriSpineLC - Lumbar Cage System	2014-03-20
PMN K133893 SAFE ORTHOPAEDICS	STERISPINE LC CAGE	2014-03-14
PMN K130632 | NKB David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2013-05-22
PMN K130632 | MNI David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2013-05-22
PMN K130632 | MNH David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2013-05-22
PMN K130632 | KWP David Lennarz [Safe Orthopaedics]	SteriSpine PS System	2013-05-22
PMN K130632 SAFE ORTHOPAEDICS	STERISPINE PS PEDICLE SCREW	2013-05-03
HXP David Lennarz [Safe Orthopaedics]	SteriSpine PS Bender	2013-01-07
PMN K122021 | MAX David Lennarz [Safe Orthopaedics]	TLSANC800 - CAGE PUSHER	2012-10-20
PMN K122021 | MAX David Lennarz [Safe Orthopaedics]	TLSANC700 - CAGE INSERTER	2012-10-20
PMN K122021 | MAX David Lennarz [Safe Orthopaedics]	TLSANC600 - OSTEOTOME	2012-10-20
PMN K122021 | MAX David Lennarz [Safe Orthopaedics]	SteriSpine LC System	2012-10-20
PMN K122021 SAFE ORTHOPAEDICS	STERISPINE LC CAGE	2012-09-20
PMN K121299 | NKB David Lennarz [Safe Orthopaedics]	Sterispine	2012-08-09
PMN K121299 | MNI David Lennarz [Safe Orthopaedics]	Sterispine	2012-08-09
PMN K121299 | MNH David Lennarz [Safe Orthopaedics]	Sterispine	2012-08-09
PMN K121299 | KWP David Lennarz [Safe Orthopaedics]	Sterispine	2012-08-09
PMN K121299 SAFE ORTHOPAEDICS	STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD	2012-07-30
PMN K112453 | NKB David Lennarz [Safe Orthopaedics]	SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2011-12-14
PMN K112453 | NKB David Lennarz [Safe Orthopaedics]	PSANC027	2011-12-14
PMN K112453 | NKB David Lennarz [Safe Orthopaedics]	PSANC026	2011-12-14
PMN K112453 | MNI David Lennarz [Safe Orthopaedics]	SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2011-12-14
PMN K112453 | MNI David Lennarz [Safe Orthopaedics]	PSANC027	2011-12-14
PMN K112453 | MNI David Lennarz [Safe Orthopaedics]	PSANC026	2011-12-14
PMN K112453 | MNH David Lennarz [Safe Orthopaedics]	SteriSpine PS System, Pedicle Screw and Rod - Sterile System	2011-12-14
PMN K112453 | MNH David Lennarz [Safe Orthopaedics]	PSANC027	2011-12-14
PMN K112453 | MNH David Lennarz [Safe Orthopaedics]	PSANC026	2011-12-14
PMN K112453 SAFE ORTHOPAEDICS	STERISPINEPS PEDICLE SCREW	2011-11-15

Related Finance Registrations

NCAGE Code	FB8W1	SAFE ORTHOPAEDICS
CAGE Code	FB8W1	SAFE ORTHOPAEDICS