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 M7399832595000 CAPTIVA SPINE, INC.	Bone Graft Funnel	2025-08-27
GUDID M739983259400 CAPTIVA SPINE, INC.	Bone Impactor	2025-08-27
GUDID M7399830170010 CAPTIVA SPINE, INC.	Triangular Awl	2025-08-27
GUDID 00850065741925 CAPTIVA SPINE, INC.	EquiLOX Expandable Lumbar Cage, Anatomic	2025-08-27
GUDID 00850065741918 CAPTIVA SPINE, INC.	EquiLOX Expandable Lumbar Cage, Anatomic	2025-08-27
GUDID 00850065741901 CAPTIVA SPINE, INC.	EquiLOX Expandable Lumbar Cage, Anatomic	2025-08-27
GUDID 00850065741895 CAPTIVA SPINE, INC.	EquiLOX Expandable Lumbar Cage, Anatomic	2025-08-27
GUDID 00850065741888 CAPTIVA SPINE, INC.	EquiLOX Expandable Lumbar Cage, Anatomic	2025-08-27
GUDID 00850065741871 CAPTIVA SPINE, INC.	EquiLOX Expandable Lumbar Cage, Anatomic	2025-08-27
GUDID 00850065741857 CAPTIVA SPINE, INC.	Rasp	2025-08-27
GUDID 00850065741840 CAPTIVA SPINE, INC.	Curette - Down angled	2025-08-27
GUDID 00850065741833 CAPTIVA SPINE, INC.	Curette - Up angled	2025-08-27
GUDID 00850065741826 CAPTIVA SPINE, INC.	Curette - Right angled	2025-08-27
GUDID 00850065741819 CAPTIVA SPINE, INC.	Curette – Left angled	2025-08-27
GUDID 00850065741802 CAPTIVA SPINE, INC.	Curette - Straight	2025-08-27
GUDID 00850065741796 CAPTIVA SPINE, INC.	Distraction Paddle - 6mm	2025-08-27
GUDID 00850065741789 CAPTIVA SPINE, INC.	Shaver - 14mm	2025-08-27
GUDID 00850065741772 CAPTIVA SPINE, INC.	Shaver - 13mm	2025-08-27
GUDID 00850065741765 CAPTIVA SPINE, INC.	Shaver - 12mm	2025-08-27
GUDID 00850065741758 CAPTIVA SPINE, INC.	Shaver - 11mm	2025-08-27
GUDID 00850065741741 CAPTIVA SPINE, INC.	Shaver - 10mm	2025-08-27
GUDID 00850065741734 CAPTIVA SPINE, INC.	Shaver - 9mm	2025-08-27
GUDID 00850065741727 CAPTIVA SPINE, INC.	Shaver - 8mm	2025-08-27
GUDID 00850065741710 CAPTIVA SPINE, INC.	Shaver - 7mm	2025-08-27
GUDID 00850065741703 CAPTIVA SPINE, INC.	Shaver - 6mm	2025-08-27
GUDID 00850065741697 CAPTIVA SPINE, INC.	Distraction Paddle - 14mm	2025-08-27
GUDID 00850065741680 CAPTIVA SPINE, INC.	Distraction Paddle - 13mm	2025-08-27
GUDID 00850065741673 CAPTIVA SPINE, INC.	Distraction Paddle - 12mm	2025-08-27
GUDID 00850065741666 CAPTIVA SPINE, INC.	Distraction Paddle - 11mm	2025-08-27
GUDID 00850065741659 CAPTIVA SPINE, INC.	Distraction Paddle - 10mm	2025-08-27
GUDID 00850065741642 CAPTIVA SPINE, INC.	Distraction Paddle - 9mm	2025-08-27
GUDID 00850065741635 CAPTIVA SPINE, INC.	Distraction Paddle - 8mm	2025-08-27
GUDID 00850065741628 CAPTIVA SPINE, INC.	Distraction Paddle - 7mm	2025-08-27
GUDID 00850065741611 CAPTIVA SPINE, INC.	Trial 12mm	2025-08-27
GUDID 00850065741604 CAPTIVA SPINE, INC.	Trial 11mm	2025-08-27
GUDID 00850065741598 CAPTIVA SPINE, INC.	Trial 10mm	2025-08-27
GUDID 00850065741581 CAPTIVA SPINE, INC.	Trial 9mm	2025-08-27
GUDID 00850065741574 CAPTIVA SPINE, INC.	Trial 8mm	2025-08-27
GUDID 00850065741567 CAPTIVA SPINE, INC.	Trial 7mm	2025-08-27
GUDID 00850065741864 CAPTIVA SPINE, INC.	Cage Holder – Center Shaft	2025-08-18
GUDID M739FCI0200 CAPTIVA SPINE, INC.	FuseLOX Cervical Inserter Shaft	2025-06-23
GUDID M739161554200 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 200mm	2025-05-28
GUDID M739161554180 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 180mm	2025-05-28
GUDID M739161554160 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 160mm	2025-05-28
GUDID M739161554140 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 140mm	2025-05-28
GUDID M739161554120 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 120mm	2025-05-28
GUDID M739161554110 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 110mm	2025-05-28
GUDID M739161554100 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 100mm	2025-05-28
GUDID M739161554095 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 95mm	2025-05-28
GUDID M739161554090 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 90mm	2025-05-28
GUDID M739161554085 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 85mm	2025-05-28
GUDID M739161554080 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 80mm	2025-05-28
GUDID M739161554075 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 75mm	2025-05-28
GUDID M739161554070 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 70mm	2025-05-28
GUDID M739161554065 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 65mm	2025-05-28
GUDID M739161554060 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 60mm	2025-05-28
GUDID M739161554055 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 55mm	2025-05-28
GUDID M739161554050 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 50mm	2025-05-28
GUDID M739161554045 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 45mm	2025-05-28
GUDID M739161554040 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 40mm	2025-05-28
GUDID M739161554035 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 35mm	2025-05-28
GUDID M739161554030 CAPTIVA SPINE, INC.	MIS Curved Rod, Ø5.5 x 30mm	2025-05-28
GUDID 00850065741550 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741543 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741536 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741529 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741512 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741505 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741499 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741482 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741475 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741468 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741451 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741444 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741437 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741420 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741413 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741406 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741390 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID 00850065741383 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2025-03-13
GUDID M739983227007 CAPTIVA SPINE, INC.	Palm Handle	2025-03-12
GUDID 00850065741376 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Holder shaft	2024-12-02
GUDID 00850065741369 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Bone Graft Funnel	2024-12-02
GUDID 00850065741352 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage - Graft Impactor	2024-12-02
GUDID 00850065741345 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-12-02
GUDID 00850065741338 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-12-02
GUDID 00850065741321 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-12-02
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 00850065741086 CAPTIVA SPINE, INC.	EquiLOX Lumbar Expandable Cage	2024-07-22
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