Captiva Spine Inc

FDA Filings

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

Captiva Spine Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT

FDA Registration(s)

• Registration Number: 3006082533
• FEI Number: 3006082533
• Name: CAPTIVA SPINE, Inc.
• Owner & Operator: CAPTIVA SPINE
• Contact Address: 967 Alternate A1A SUITE 1; Jupiter FL 33477 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 967 N HIGHWAY A1A ALT STE 1 ; Jupiter, FL 33477 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850065741260 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Torque Handle (2.5 Nm)	2024-07-24
GUDID 00850065741253 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Square Cage Driver (AO connector)	2024-07-24
GUDID 00850065741246 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Holder shaft	2024-07-24
GUDID 00850065741239 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Slap Hammer (tuning fork style)	2024-07-24
GUDID 00850065741079 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Bone Impactor	2024-07-24
GUDID 00850065741062 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Bone Graft Funnel	2024-07-24
GUDID 00850065741055 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Hammer power shaft	2024-07-24
GUDID 00850065741048 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Hammer connecting shaft	2024-07-24
GUDID 00850065741031 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Square Cage Driver	2024-07-24
GUDID 00850065741024 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Cage Holder (w retention rod)	2024-07-24
GUDID 00850065741017 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Funnel	2024-07-24
GUDID 00850065741000 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Bone Impactor	2024-07-24
GUDID 00850065741222 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741215 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741208 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741192 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741185 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741178 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage 00850065741178	2024-07-22
GUDID 00850065741161 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741154 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741147 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741130 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741123 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741116 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741109 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741093 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID 00850065741086 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
GUDID M73910290180 CAPTIVA SPINE, INC.	TransFasten - LSF, Parallel Guide	2024-05-03
GUDID M73910290170 CAPTIVA SPINE, INC.	TransFasten - LSF, Open-Ended Offset Guide	2024-05-03
GUDID M73910290160 CAPTIVA SPINE, INC.	TransFasten - LSF, K-wire	2024-05-03
GUDID M73910290150 CAPTIVA SPINE, INC.	TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mm	2024-05-03
GUDID M73910290140 CAPTIVA SPINE, INC.	TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mm	2024-05-03
GUDID M73910290130 CAPTIVA SPINE, INC.	TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mm	2024-05-03
GUDID M73910290120 CAPTIVA SPINE, INC.	TransFasten - LSF, Quick Connect Handle	2024-05-03
GUDID M73910290110 CAPTIVA SPINE, INC.	TransFasten - LSF, Implant Filling Tube	2024-05-03
GUDID M739102901009 CAPTIVA SPINE, INC.	TransFasten-LSF, Plunger Rod	2024-05-03
GUDID M73910290070 CAPTIVA SPINE, INC.	TransFasten-LSF, Tissue Dilator	2024-05-03
GUDID M73910290060 CAPTIVA SPINE, INC.	TransFasten-LSF, Offset Guide	2024-05-03
GUDID M73910290050 CAPTIVA SPINE, INC.	TransFasten-LSF, Implant Driver Shaft	2024-05-03
GUDID M73910290030 CAPTIVA SPINE, INC.	TransFasten-LSF, Tissue Protector	2024-05-03
GUDID M73910290020 CAPTIVA SPINE, INC.	TransFasten - LSF, Quick Connect Drill	2024-05-03
GUDID M739102900109 CAPTIVA SPINE, INC.	TransFasten - LSF, General Instrument Tray	2024-05-03
GUDID M739985222229 CAPTIVA SPINE, INC.	TransFasten	2024-03-19
GUDID M739985221305 CAPTIVA SPINE, INC.	TransFasten	2024-03-19
GUDID M739985221229 CAPTIVA SPINE, INC.	TransFasten	2024-03-19
GUDID M739203000210 CAPTIVA SPINE, INC.	4-Hole Drill Guide	2024-03-19
GUDID M73910110650 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110600 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110550 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110500 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110450 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110400 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110350 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110300 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M73910110250 CAPTIVA SPINE, INC.	TransFasten - LSF (Lateral Sacroiliac Fusion System)	2024-03-11
GUDID M739203000400N0 CAPTIVA SPINE, INC.	Dissector	2024-01-22
GUDID M739203000200N0 CAPTIVA SPINE, INC.	4-Hole Drill Guide	2024-01-22
GUDID M739FPT0102 CAPTIVA SPINE, INC.	Inserter Shaft	2023-10-24
GUDID M739FPT01000 CAPTIVA SPINE, INC.	Inserter Base	2023-10-24
GUDID M739CP50901 CAPTIVA SPINE, INC.	Implant Caddy	2023-10-09
GUDID M73922010907 CAPTIVA SPINE, INC.	Set Screw Caddy	2023-10-09
GUDID M73922010906 CAPTIVA SPINE, INC.	Cross Connector Caddy	2023-10-09
GUDID M739164311900 CAPTIVA SPINE, INC.	Caddy Tray - 8.5mm / 9.0mm Screws	2023-10-09
GUDID M739164017036 CAPTIVA SPINE, INC.	Set Screw Caddy Assembly	2023-10-09
GUDID M739164017034 CAPTIVA SPINE, INC.	EXT Cap Caddy Assembly	2023-10-09
GUDID M739164017032 CAPTIVA SPINE, INC.	Tower Screw Caddy Assembly	2023-10-09
GUDID M739134000907 CAPTIVA SPINE, INC.	Screw Caddy	2023-10-09
GUDID M22010904 CAPTIVA SPINE, INC.	Pedicle Screw Caddy	2023-10-09
GUDID M154010906 CAPTIVA SPINE, INC.	Cross Connector Caddy ML	2023-10-09
GUDID M739CP30036 CAPTIVA SPINE, INC.	2-Level Cervical Plates, 36 mm	2023-09-18
GUDID M739CP300340 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 34 mm	2023-09-18
GUDID M739CP30034 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 34 mm	2023-09-18
GUDID M739CP300320 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 32 mm	2023-09-18
GUDID M739CP30032 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 32 mm	2023-09-18
GUDID M739CP300300 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 30 mm	2023-09-18
GUDID M739CP30030 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 30 mm	2023-09-18
GUDID M739CP300280 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 28 mm	2023-09-18
GUDID M739CP30028 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 28 mm	2023-09-18
GUDID M739CP300260 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 26 mm	2023-09-18
GUDID M739CP30026 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 26 mm	2023-09-18
GUDID M739CP300240 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 24 mm	2023-09-18
GUDID M739CP30024 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 24 mm	2023-09-18
GUDID M739CP300220 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 22 mm	2023-09-18
GUDID M739CP30022 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 22 mm	2023-09-18
GUDID M739CP300200 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 20 mm	2023-09-18
GUDID M739CP30020 CAPTIVA SPINE, INC.	1-Level Cervical Plates, 20 mm	2023-09-18
GUDID M739985147508 CAPTIVA SPINE, INC.	Guidewire, Nitinol, Non-Threaded	2023-09-18
GUDID M73924714975 CAPTIVA SPINE, INC.	Cross Connector, Large	2023-09-18
GUDID M73924714963 CAPTIVA SPINE, INC.	Cross Connector, Medium-Large	2023-09-18
GUDID M73924713752 CAPTIVA SPINE, INC.	Cross Connector, Medium	2023-09-18
GUDID M73924713139 CAPTIVA SPINE, INC.	Cross Connector, Small	2023-09-18
GUDID M73924712832 CAPTIVA SPINE, INC.	Cross Connector, XSmall	2023-09-18
GUDID M739131164018 CAPTIVA SPINE, INC.	Fixed Screw, Self-Tapping, 4.0mm x 18mm	2023-09-18
GUDID M739131164016 CAPTIVA SPINE, INC.	Fixed Screw, Self-Tapping, 4.0mm x 16mm	2023-09-18
GUDID M739131164014 CAPTIVA SPINE, INC.	Fixed Screw, Self-Tapping, 4.0mm x 14mm	2023-09-18
GUDID M739131164012 CAPTIVA SPINE, INC.	Fixed Screw, Self-Tapping, 4.0mm x 12mm	2023-09-18
GUDID M739131064018 CAPTIVA SPINE, INC.	Variable Screw, Self-Tapping, 4.0mm x 18mm	2023-09-18
GUDID M739131064016 CAPTIVA SPINE, INC.	Variable Screw, Self-Tapping, 4.0mm x 16mm	2023-09-18
GUDID M739131064014 CAPTIVA SPINE, INC.	Variable Screw, Self-Tapping, 4.0mm x 14mm	2023-09-18
GUDID M739131064012 CAPTIVA SPINE, INC.	Variable Screw, Self-Tapping, 4.0mm x 12mm	2023-09-18
PMN K193270 | NKB CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2020-03-02
PMN K193270 | NKB CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2020-03-02
PMN K193270 | NKB CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II / TowerLOX MIS Pedicle Screw System	2020-03-02
PMN K193270 Captiva Spine, Inc.	CapLOX II®/TowerLOX® MIS Pedicle Screw System	2020-01-31
HXL CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Mallet	2019-07-25
HTW CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Center Hole Reamer	2019-07-25
HTW CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Anchor Pin	2019-07-25
HTW CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	4-Hole Drill	2019-07-25
FZX CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Sheath	2019-07-25
FZX CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Marking Guide	2019-07-25
FZX CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	4-Hole Drill Guide	2019-07-25
PMN K181229 | ODP CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TirboLOX-C Cervical IBFD	2019-05-20
PMN K180990 | MAX CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TirboLOX-L Lumbar IBFD	2019-02-25
PMN K181229 Captiva Spine, Inc.	TirboLOX-C Cervical IBFD	2018-09-19
PMN K180990 Captiva Spine, Inc.	TirboLOX-L Lumbar IBFD	2018-08-13
PMN K180475 | NKB CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX MIS Ext Pedicle Screw System	2018-05-24
PMN K180475 Captiva Spine, Inc.	CapLOX II® / TowerLOX® MIS Pedicle Screw System	2018-03-19
PMN K160020 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2016-09-16
PMN K160020 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2016-09-16
PMN K160020 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2016-09-16
PMN K160020 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2016-09-16
PMN K141332 | KWQ CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	SmartLOX Cervical Plate System	2015-10-19
PMN K151116 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2015-09-15
PMN K151116 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II	2015-09-15
PMN K151116 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2015-09-15
PMN K151116 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2015-09-15
PMN K151116 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II	2015-09-15
PMN K151116 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2015-09-15
PMN K142586 | ODP CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Cervical IBF System	2015-06-10
PMN K131538 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2013-08-19
PMN K131538 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2013-08-19
PMN K131538 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2013-08-19
PMN K131538 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2013-08-19
PMN K122956 | MAX CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Lumbar Interbody Fusion System	2012-12-13
PMN K122332 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2012-12-13
PMN K122332 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2012-12-13
PMN K122332 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2012-12-13
PMN K122332 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2012-12-13
PMN K120292 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2012-12-13
PMN K120292 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2012-12-13
PMN K120292 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2012-12-13
PMN K120292 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2012-12-13
PMN K111115 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2012-12-13
PMN K111115 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2012-12-13
PMN K120292 CAPTIVA SPINE, INC	CAPLOX II PEDICLE SCREW SYSTEM	2012-04-13
PMN K111115 CAPTIVA SPINE, INC	CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM	2011-09-13
PMN K110585 | ODP CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Cervical IBF System	2011-09-13
PMN K100956 | MNI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Spinal System	2011-09-13
PMN K100956 | MNH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Spinal System	2011-09-13
PMN K110585 CAPTIVA SPINE, INC	CAPTIVA SPINE FUSELOX CERVICAL CAGE	2011-03-25
PMN K073708 | KWQ CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	SmartLox	2010-10-21
PMN K092017 | MAX CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Pivotec	2009-12-08
LXH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2009-12-08
LXH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	SmartLOX	2009-12-08
LXH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Pivotec	2009-12-08
LXH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Lumbar Interbody Fusion System	2009-12-08
LXH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Cervical IBF System	2009-12-08
LXH CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2009-12-08
HXG CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Pivotec	2009-12-08
HXG CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Lumbar Interbody Fusion System	2009-12-08
HXG CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Cervical IBF System	2009-12-08
HTF CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Pivotec	2009-12-08
HTF CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Lumbar Interbody Fusion System	2009-12-08
GFI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Pivotec	2009-12-08
GFI CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Lumbar Interbody Fusion System	2009-12-08
FSM CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX Pedicle Screw System	2009-12-08
FSM CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	SmartLOX	2009-12-08
FSM CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	Pivotec	2009-12-08
FSM CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Lumbar Interbody Fusion System	2009-12-08
FSM CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Cervical IBF System	2009-12-08
FSM CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	CapLOX II Pedicle Screw System	2009-12-08
PMN K092017 CAPTIVA SPINE, INC	PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)	2009-12-01