Spinal Elements

FDA Filings

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

FDA Registration(s)

• Registration Number: 3012341129
• FEI Number: 3012341129
• Name: Spinal Elements
• Owner & Operator: Spinal Elements
• Contact Address: 3115 Melrose Dr Suite 200 ; Carlsbad CA 92010 US
• Official Correspondent:
  • Jason Blain
  • x-760-6071812-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 47354 Fremont Blvd. ; Fremont, CA 94538 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3004893332
• FEI Number: 3004893332
• Name: SPINAL ELEMENTS, INC.
• Owner & Operator: Spinal Elements
• Contact Address: 3115 Melrose Dr Suite 200 ; Carlsbad CA 92010 US
• Official Correspondent:
  • Jason Blain
  • x-760-6071812-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3115 Melrose Dr Suite 200 ; CARLSBAD, CA 92010 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00840916161866 SPINAL ELEMENTS	ZEUS-L	2023-05-03
GUDID 00840916161859 SPINAL ELEMENTS	ZEUS-L	2023-05-03
GUDID 00840916161842 SPINAL ELEMENTS	ZEUS-L	2023-05-03
GUDID 00840916150693 SPINAL ELEMENTS	SAVANNAH	2022-03-30
GUDID 00840916162146 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162139 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162122 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162115 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162108 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162092 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162085 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162078 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162061 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162054 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162047 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162030 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162023 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162009 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916161996 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916161989 SPINAL ELEMENTS	DIAMOND	2022-03-11
GUDID 00840916162160 SPINAL ELEMENTS	OMEGALIF	2022-03-04
GUDID 00840916148546 SPINAL ELEMENTS	OMEGALIF	2022-03-04
GUDID 00840916155742 SPINAL ELEMENTS	SAVANNAH	2021-10-07
GUDID 00840916155735 SPINAL ELEMENTS	SAVANNAH	2021-10-07
GUDID 00840916161941 SPINAL ELEMENTS	CERES	2021-07-02
GUDID 00840916161934 SPINAL ELEMENTS	CERES	2021-07-02
GUDID 00840916161927 SPINAL ELEMENTS	CERES	2021-07-02
GUDID 00840916161972 SPINAL ELEMENTS	SAVANNAH	2021-06-15
GUDID 00840916161965 SPINAL ELEMENTS	SAVANNAH	2021-06-15
GUDID 00840916161958 SPINAL ELEMENTS	SAVANNAH	2021-06-15
GUDID 00840916161910 SPINAL ELEMENTS	ZEUS-P	2021-05-05
GUDID 00840916161903 SPINAL ELEMENTS	ZEUS-P	2021-05-05
GUDID 00840916161897 SPINAL ELEMENTS	ZEUS-P	2021-05-05
GUDID 00840916161880 SPINAL ELEMENTS	ZEUS-P	2021-05-05
GUDID 00840916161873 SPINAL ELEMENTS	ZEUS-P	2021-05-05
GUDID 00840916161835 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161828 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161811 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161804 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161798 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161781 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161774 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161767 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161750 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161743 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161736 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161729 SPINAL ELEMENTS	ZEUS-T	2021-05-05
GUDID 00840916161705 SPINAL ELEMENTS	OVERWATCH	2021-04-13
GUDID 00840916161699 SPINAL ELEMENTS	OVERWATCH	2021-04-13
GUDID 00840916161712 SPINAL ELEMENTS	ZEUS-A	2021-03-16
GUDID 00840916160487 SPINAL ELEMENTS	PIRANHA	2021-03-16
GUDID 00840916160470 SPINAL ELEMENTS	PIRANHA	2021-03-16
GUDID 00840916160463 SPINAL ELEMENTS	PIRANHA	2021-03-16
GUDID 00840916155551 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916155544 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916155537 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148850 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148843 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148836 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148829 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148812 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148805 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148799 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148782 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148775 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148768 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148744 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148737 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148720 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148713 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148706 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916148690 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840606158930 SPINAL ELEMENTS	OVERWATCH	2021-02-25
GUDID 00840916161682 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161675 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161668 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161651 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161644 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161637 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161620 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161613 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161606 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161590 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161583 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161576 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161569 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161552 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161545 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161538 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161521 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161514 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161507 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161491 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161484 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916161477 SPINAL ELEMENTS	ZEUS-T	2021-02-09
GUDID 00840916156305 SPINAL ELEMENTS	TALON	2021-02-09
GUDID 00840916150655 SPINAL ELEMENTS	SAVANNAH	2021-01-28
GUDID 00840916150648 SPINAL ELEMENTS	SAVANNAH	2021-01-28
GUDID 00840916150631 SPINAL ELEMENTS	SAVANNAH	2021-01-28
GUDID 00840916150624 SPINAL ELEMENTS	SAVANNAH	2021-01-28
PMN K190289 | OWI SPINAL ELEMENTS, INC. [Spinal Elements]	Karma? Fixation System	2019-04-04
PMN K113533 | HAE Spinal Elements	iO-Flex	2015-03-19
PMN K110696 | ETN Spinal Elements	iO-Flex Neuro Check	2015-03-19
PMN K102594 | BSO Spinal Elements	iO-Flex	2015-03-19
PMN K100958 | HAE Spinal Elements	iO-Flex	2015-03-19
PMN K100958 | HAE Spinal Elements	iO-Flex MicroBlade Shaver	2015-03-19
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Wrench	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tulip Positioner	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tulip Adjuster	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Trial	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Trephine	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tower Clip	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Temporary Fixation Screw	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Temporary Fixation Pin	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tap	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tamp	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tab Extender	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tab Cutter	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Tab Breaker	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Suction Tube	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Stabilizer	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Spacer	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Sleeve	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Sizer	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Set Screw Starter	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Screwdriver	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Screw Adjuster	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Rongeur	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Rod Template	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Rod Holder	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Rod Gripper	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Rod Bender	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Rocker	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Retractor	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Retainer	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Removal Tool	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Reducer	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Rasp	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Pusher	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Probe	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Post Remover	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Plate Shaver	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Plate Holder	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Plate Bender	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Pin Inserter	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Persuader	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Pedicle Marker	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Pedicle Feeler	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Packing Block	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Osteotome	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Nerver Root Retractor	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Nerve Sheild	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Marquise MIS Channel	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Lodestar	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Inserter	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Hex Retainer	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Hex Driver	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Hex Adapter	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Handle	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Hammer	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Guide	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Guide Wire	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Graft Block	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Funnel	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Elevator	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Ejector	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Dual Stylet Needle	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Drill	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Distractor	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Distraction Pin	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Distraction Pin Driver	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Disc Shaver	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Disc Shaper	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Disc Cutter	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Dilator	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Depth Tool	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Depth Sounder	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Curette	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Crown	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Crow Foot	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Counter Torque	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Compressor	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Compressor Fulcrum	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Compactor	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Cobb	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Chisel	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Cannula	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Caliper	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Broach	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Box Chisel	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Awl	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Adaptor	2012-10-26
LXH SPINAL ELEMENTS, INC. [Spinal Elements]	Access Portal	2012-10-26

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