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 Number3012341129
FEI Number3012341129
NameSpinal Elements
Owner & OperatorSpinal Elements
Contact Address3115 Melrose Dr Suite 200
Carlsbad CA 92010 US
Official Correspondent
  • Jason Blain
  • x-760-6071812-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address47354 Fremont Blvd.
Fremont, CA 94538 US
Establishment TypeManufacture Medical Device



Registration Number3004893332
FEI Number3004893332
NameSPINAL ELEMENTS, INC.
Owner & OperatorSpinal Elements
Contact Address3115 Melrose Dr Suite 200
Carlsbad CA 92010 US
Official Correspondent
  • Jason Blain
  • x-760-6071812-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3115 Melrose Dr Suite 200
CARLSBAD, CA 92010 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
SPINAL ELEMENTS
Optimus 2020-07-03
SPINAL ELEMENTS
Optimus 2020-07-03
SPINAL ELEMENTS
Optimus 2020-07-03
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-O 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-O 2020-05-19
SPINAL ELEMENTS
Zeus-O 2020-05-19
SPINAL ELEMENTS
Zeus-O 2020-05-19
SPINAL ELEMENTS
Zeus-O 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-19
SPINAL ELEMENTS
Zeus-O 2020-05-19
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Zeus-L 2020-05-18
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Talon 2020-05-13
SPINAL ELEMENTS
Talon 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Savannah-T 2020-05-13
SPINAL ELEMENTS
Spartan 2020-05-13
SPINAL ELEMENTS
Spartan 2020-05-13
SPINAL ELEMENTS
Spartan 2020-05-13
SPINAL ELEMENTS
Spartan 2020-05-13
SPINAL ELEMENTS
Spartan 2020-05-13
SPINAL ELEMENTS
Spartan 2020-05-13
SPINAL ELEMENTS, INC. [Spinal Elements]
Karma? Fixation System2019-04-04
Spinal Elements
iO-Flex2015-03-19
Spinal Elements
iO-Flex Neuro Check2015-03-19
Spinal Elements
iO-Flex2015-03-19
Spinal Elements
iO-Flex2015-03-19
Spinal Elements
iO-Flex MicroBlade Shaver2015-03-19
SPINAL ELEMENTS, INC. [Spinal Elements]
Wrench2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tulip Positioner2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tulip Adjuster2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Trial2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Trephine2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tower Clip2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Temporary Fixation Screw2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Temporary Fixation Pin2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tap2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tamp2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tab Extender2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tab Cutter2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Tab Breaker2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Suction Tube2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Stabilizer2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Spacer2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Sleeve2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Sizer2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Set Screw Starter2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Screwdriver2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Screw Adjuster2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Rongeur2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Rod Template2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Rod Holder2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Rod Gripper2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Rod Bender2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Rocker2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Retractor2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Retainer2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Removal Tool2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Reducer2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Rasp2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Pusher2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Probe2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Post Remover2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Plate Shaver2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Plate Holder2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Plate Bender2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Pin Inserter2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Persuader2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Pedicle Marker2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Pedicle Feeler2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Packing Block2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Osteotome2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Nerver Root Retractor2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Nerve Sheild2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Marquise MIS Channel2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Lodestar2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Inserter2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Hex Retainer2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Hex Driver2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Hex Adapter2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Handle2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Hammer2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Guide2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Guide Wire2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Graft Block2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Funnel2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Elevator2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Ejector2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Dual Stylet Needle2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Drill2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Distractor2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Distraction Pin2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Distraction Pin Driver2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Disc Shaver2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Disc Shaper2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Disc Cutter2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Dilator2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Depth Tool2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Depth Sounder2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Curette2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Crown2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Crow Foot2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Counter Torque2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Compressor2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Compressor Fulcrum2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Compactor2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Cobb2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Chisel2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Cannula2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Caliper2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Broach2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Box Chisel2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Awl2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Adaptor2012-10-26
SPINAL ELEMENTS, INC. [Spinal Elements]
Access Portal2012-10-26

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