CAPTIVA SPINE, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3006082533	3006082533	CAPTIVA SPINE, Inc.	1	Y	2026-01-01	967 N HIGHWAY A1A ALT STE 1 Jupiter FL US 33477

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
67756	1290795424	K232069	Expandable Lumbar Fusion Cage (Type I,Type II)	MAX	2023-11-29
67756	1867525509	K193270	CapLOX II®/TowerLOX® MIS Pedicle Screw System	NKB	2020-01-31
67756	1887428531	K181229	TirboLOX-C Cervical IBFD	ODP	2018-09-19
67756	1619481041	K180990	TirboLOX-L Lumbar IBFD	MAX	2018-08-13
67756	1241198714	K180475	CapLOX II® / TowerLOX® MIS Pedicle Screw System	NKB	2018-03-19
67756	1095850841	K170475	SICAGE™ System	OUR	2017-05-05
67756	1768447887	K160020	Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System	MNH	2016-03-02
67756	1274931295	K151116	CapLOX II/TowerLOX Pedicle Screw System	MNH	2015-06-26
67756	1554749616	K142586	Captiva Spine FuselOX Cervical IBF System	ODP	2015-05-28
67756	2048297860	K141332	Captiva Spine SmartLOX Cervical Plate System	KWQ	2015-06-11
67756	1407089918	K131538	CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM	MNH	2013-08-08
67756	1950186819	K122956	FUSELOX LUMBAR INTERBODY FUSION DEVICE	MAX	2012-10-25
67756	2042927762	K122332	TOWERLOX PEDICLE SCREW SYSTEM	MNI	2012-10-16
67756	1691368982	K120292	CAPLOX II PEDICLE SCREW SYSTEM	MNI	2012-04-13
67756	1174004043	K111115	CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM	MNI	2011-09-13
67756	1510853691	K110585	CAPTIVA SPINE FUSELOX CERVICAL CAGE	ODP	2011-03-25
67756	1998462445	K100956	SPONDY SPINAL FIXATION SYSTEM	MNH	2010-07-09
67756	1539407894	K092017	PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)	MAX	2009-12-01
67756	1192979118	K073708	FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM	KWQ	2008-06-03
67756	1209258478
67756	1348861849
67756	1428887016
67756	1564077415
67756	1772649222
67756	1815518912
67756	1856962411
67756	2066441897
67756	1521992204
67756	1890460048

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MNH	8	2016-03-02
MAX	7	2023-11-29
ODP	6	2018-09-19
MNI	6	2012-10-16
NKB	4	2020-01-31
KWQ	4	2015-06-11
OUR	1	2017-05-05

PMN#

CapLOX II®/TowerLOX® MIS Pedicle Screw System
2020-01-31
Captiva Spine, Inc.
TirboLOX-C Cervical IBFD
2018-09-19
Captiva Spine, Inc.
TirboLOX-L Lumbar IBFD
2018-08-13
Captiva Spine, Inc.
CapLOX II® / TowerLOX® MIS Pedicle Screw System
2018-03-19
Captiva Spine, Inc.

GUDID#

Variable Screw, Self-Tapping, 4.0mm x 12mm - 13106-4012
CAPTIVA SPINE, INC.
2015-10-30
Variable Screw, Self-Tapping, 4.0mm x 14mm - 13106-4014
CAPTIVA SPINE, INC.
2015-10-30
Variable Screw, Self-Tapping, 4.0mm x 16mm - 13106-4016
CAPTIVA SPINE, INC.
2015-10-30
Variable Screw, Self-Tapping, 4.0mm x 18mm - 13106-4018
CAPTIVA SPINE, INC.
2015-10-30
Fixed Screw, Self-Tapping, 4.0mm x 12mm - 13116-4012
CAPTIVA SPINE, INC.
2015-10-30
Fixed Screw, Self-Tapping, 4.0mm x 14mm - 13116-4014
CAPTIVA SPINE, INC.
2015-10-30
Fixed Screw, Self-Tapping, 4.0mm x 16mm - 13116-4016
CAPTIVA SPINE, INC.
2015-10-30
Fixed Screw, Self-Tapping, 4.0mm x 18mm - 13116-4018
CAPTIVA SPINE, INC.
2015-10-30
Cross Connector, XSmall - 2471-2832
CAPTIVA SPINE, INC.
2015-10-30
Cross Connector, Small - 2471-3139
CAPTIVA SPINE, INC.
2015-10-30
Cross Connector, Medium - 2471-3752
CAPTIVA SPINE, INC.
2015-10-30
Cross Connector, Medium-Large - 2471-4963
CAPTIVA SPINE, INC.
2015-10-30
Cross Connector, Large - 2471-4975
CAPTIVA SPINE, INC.
2015-10-30
1-Level Cervical Plates, 20 mm - CP30020
CAPTIVA SPINE, INC.
2015-10-30
1-Level Cervical Plates, 20 mm - CP30020
CAPTIVA SPINE, INC.
2017-08-11
1-Level Cervical Plates, 22 mm - CP30022
CAPTIVA SPINE, INC.
2015-08-28
1-Level Cervical Plates, 22 mm - CP30022
CAPTIVA SPINE, INC.
2017-08-11
1-Level Cervical Plates, 24 mm - CP30024
CAPTIVA SPINE, INC.
2015-08-28
1-Level Cervical Plates, 24 mm - CP30024
CAPTIVA SPINE, INC.
2017-08-11
1-Level Cervical Plates, 26 mm - CP30026
CAPTIVA SPINE, INC.
2015-08-28
1-Level Cervical Plates, 26 mm - CP30026
CAPTIVA SPINE, INC.
2017-08-11
1-Level Cervical Plates, 28 mm - CP30028
CAPTIVA SPINE, INC.
2015-08-28
1-Level Cervical Plates, 28 mm - CP30028
CAPTIVA SPINE, INC.
2017-08-11
1-Level Cervical Plates, 30 mm - CP30030
CAPTIVA SPINE, INC.
2015-08-28
1-Level Cervical Plates, 30 mm - CP30030
CAPTIVA SPINE, INC.
2017-08-11
1-Level Cervical Plates, 32 mm - CP30032
CAPTIVA SPINE, INC.
2015-08-28
1-Level Cervical Plates, 32 mm - CP30032
CAPTIVA SPINE, INC.
2017-08-11
1-Level Cervical Plates, 34 mm - CP30034
CAPTIVA SPINE, INC.
2015-08-28
1-Level Cervical Plates, 34 mm - CP30034
CAPTIVA SPINE, INC.
2017-08-11
2-Level Cervical Plates, 36 mm - CP30036
CAPTIVA SPINE, INC.
2015-08-28
2-Level Cervical Plates, 36 mm - CP30036
CAPTIVA SPINE, INC.
2017-08-11
2-Level Cervical Plates, 38mm - CP30038
CAPTIVA SPINE, INC.
2015-08-28
2-Level Cervical Plates, 38 mm - CP30038
CAPTIVA SPINE, INC.
2017-08-11
2-Level Cervical Plates, 40 mm - CP30040
CAPTIVA SPINE, INC.
2015-08-28
2-Level Cervical Plates, 40 mm - CP30040
CAPTIVA SPINE, INC.
2017-08-11
2-Level Cervical Plates, 42 mm - CP30042
CAPTIVA SPINE, INC.
2015-08-28
2-Level Cervical Plates, 42 mm - CP30042
CAPTIVA SPINE, INC.
2017-08-11
2-Level Cervical Plates, 44 mm - CP30044
CAPTIVA SPINE, INC.
2015-08-28
2-Level Cervical Plates, 44 mm - CP30044
CAPTIVA SPINE, INC.
2017-08-11
2-Level Cervical Plates, 46 mm - CP30046
CAPTIVA SPINE, INC.
2015-08-28

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