Spinal Elements

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3012341129	3012341129	Spinal Elements	1	N	2020-04-25	47354 Fremont Blvd. Fremont CA US 94538

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
194781	1404289978	K113533	NEURO CHECK DEVICE WITH IO-FLEX WIRE	HAE	2012-04-11
194781	1875809828	K110696	NEURO CHECK DEVICE WITH IO-FLEX WIRE	ETN	2011-07-07
194781	1149538551	K102594	IO-FLEX CATHETER	BSO	2011-01-19
194781	1094179653	K100958	MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES	HAE	2010-07-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
HAE	2	2012-04-11
ETN	1	2011-07-07
BSO	1	2011-01-19

GUDID#

ZEUS-T - Zeus-T Bullet-Nose Assembly 12 x 28mm Curved Cage
SPINAL ELEMENTS
2017-08-01
DIAMOND - DIAMOND 4.0MM SCREW CADDY
SPINAL ELEMENTS
2022-03-03
DIAMOND - DIAMOND 4.3MM SCREW CADDY
SPINAL ELEMENTS
2022-03-03
DIAMOND - DIAMOND 1/2 LEVEL PLATE CADDY
SPINAL ELEMENTS
2022-03-03
ZEUS-O - Zeus®-O Disc Cutter
SPINAL ELEMENTS
2021-01-11
ZEUS-O - Neuro Monitoring Pribe Sleeve
SPINAL ELEMENTS
2021-01-11
SPARTAN - SPARTAN SCREW SHIRT WASHER
SPINAL ELEMENTS
2020-12-07
ZEUS-O - ZEUS®-O CURVED ROD INSERTER ASSEMBLY
SPINAL ELEMENTS
2020-05-11
SLPSS - SLPSS Coupler
SPINAL ELEMENTS
2017-08-10
SAVANNAH - HEX ADAPTER
SPINAL ELEMENTS
2020-04-16
SAVANNAH - CROW FOOT SIDEBAR
SPINAL ELEMENTS
2020-04-16
SAVANNAH - CANNULATED HEX DRIVER
SPINAL ELEMENTS
2020-04-16
SAVANNAH - HEX RETAINER
SPINAL ELEMENTS
2020-04-16
SAVANNAH - CANNULATED TAP
SPINAL ELEMENTS
2020-04-16
SAVANNAH - COUPLER PUSHER ASSEMBLY
SPINAL ELEMENTS
2020-04-16
SAVANNAH - PEDICLE FEELER
SPINAL ELEMENTS
2020-04-16
SAMSON - Samson Corpectomy Implant, 14mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 15mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 16mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 17mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 18mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 19mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 20mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 21mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 22mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 23mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 24mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 25mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 26mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 27mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 28mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 29mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 30mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 31mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 32mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 33mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 34mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 35mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 36mm
SPINAL ELEMENTS
2017-08-01
SAMSON - Samson Corpectomy Implant, 37mm
SPINAL ELEMENTS
2017-08-01

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