# Captiva Spine, Inc.

- Location (FDA's records): Jupiter, FL
- FDA decisions: 15 (2009–2020): 15 510(k) clearances
- Names in FDA's records: Captiva Spine, Inc. (8); Captiva Spine (7)
- Product codes: MNI (3), MNH (3), MAX (3), ODP (3), NKB (2), KWQ (1)
- 510(k) review time since 2016: median 66 days, against 93 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 44 (13 its own); citations of its devices by later devices: 20 (13 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- K2m, Inc.: 3 (https://510kreport.com/company/k2m)
- Precision Surgery, Ltd.: 2 (https://510kreport.com/company/precision-surgery)
- Transcorp: 2 (https://510kreport.com/company/transcorp)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- Allure Spine LLC: 1 (https://510kreport.com/company/allure-spine)
- U&I Corp., America: 1 (https://510kreport.com/company/u-i-america)
- Buckman Co., Inc.: 1 (https://510kreport.com/company/buckman)

## Firms that cite its devices most
- Nexus Spine, LLC: 2 (https://510kreport.com/company/nexus-spine)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)
- Osso Surgical: 1 (https://510kreport.com/company/osso-surgical)
- Shanghai Sanyou Medical Co, Ltd.: 1 (https://510kreport.com/company/shanghai-sanyou-medical)
- Pressio, Inc.: 1 (https://510kreport.com/company/pressio)
- Atlas Spine, Inc.: 1 (https://510kreport.com/company/atlas-spine)

## Its most-cited devices
- K092017: Pivotec Lumbar Interbody Fusion Device (Lifd) (2009), cited by 4
- K131538: Caplox II Pedicle Screw System/Towerlox Pedicle Screw System (2013), cited by 3
- K122332: Towerlox Pedicle Screw System (2012), cited by 3
- K111115: Captiva Spine Caplox II Spinal Fixation System (2011), cited by 2
- K151116: CapLOX II/TowerLOX Pedicle Screw System (2015), cited by 2
- K120292: Caplox II Pedicle Screw System (2012), cited by 2

## Recent decisions
- K193270: CapLOX II®/TowerLOX® MIS Pedicle Screw System (Jan 31, 2020)
- K181229: TirboLOX-C Cervical IBFD (Sep 19, 2018)
- K180990: TirboLOX-L Lumbar IBFD (Aug 13, 2018)
- K180475: CapLOX II® / TowerLOX® MIS Pedicle Screw System (Mar 19, 2018)
- K160020: Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (Mar 2, 2016)
- K151116: CapLOX II/TowerLOX Pedicle Screw System (Jun 26, 2015)
- K141332: Captiva Spine SmartLOX Cervical Plate System (Jun 11, 2015)
- K142586: Captiva Spine FuselOX Cervical IBF System (May 28, 2015)

Source page: https://510kreport.com/company/captiva-spine