Captiva Spine

FDA Filings

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

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
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
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 K180475 | NKB CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	TowerLOX MIS Ext Pedicle Screw System	2018-05-24
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 K160020 Captiva Spine	Captiva Spine And CapLOX II/TowerLOX Pedicle Screw System	2016-03-02
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 K151116 CAPTIVA SPINE	CapLOX II/TowerLOX Pedicle Screw System	2015-06-26
PMN K141332 CAPTIVA SPINE	Captiva Spine SmartLOX Cervical Plate System	2015-06-11
PMN K142586 | ODP CAPTIVA SPINE, Inc. [CAPTIVA SPINE]	FuseLOX Cervical IBF System	2015-06-10
PMN K142586 CAPTIVA SPINE	Captiva Spine FuselOX Cervical IBF System	2015-05-28
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 K131538 CAPTIVA SPINE	CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM	2013-08-08
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 K122956 CAPTIVA SPINE	FUSELOX LUMBAR INTERBODY FUSION DEVICE	2012-10-25
PMN K122332 CAPTIVA SPINE	TOWERLOX PEDICLE SCREW SYSTEM	2012-10-16
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 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

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• CAPTIVA SPINE, Inc