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FDA 510(k)

CapLOX II® / TowerLOX® MIS Pedicle Screw System

K-Number: K180475 · 2018-03-19

ApplicantCaptiva Spine, Inc.
Decision Date2018-03-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CapLOX II® / TowerLOX® MIS Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Captiva Spine, Inc.. It received FDA 510(k) clearance on 2018-03-19 under 510(k) number K180475. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CapLOX II® / TowerLOX® MIS Pedicle Screw System?

CapLOX II® / TowerLOX® MIS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-03-19. The listed applicant is Captiva Spine, Inc.. The 510(k) number is K180475.

When did CapLOX II® / TowerLOX® MIS Pedicle Screw System receive FDA 510(k) clearance?

CapLOX II® / TowerLOX® MIS Pedicle Screw System received FDA 510(k) clearance on 2018-03-19, under 510(k) number K180475.

Who is the listed applicant for CapLOX II® / TowerLOX® MIS Pedicle Screw System?

The FDA 510(k) record lists Captiva Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CapLOX II® / TowerLOX® MIS Pedicle Screw System?

The FDA product code for CapLOX II® / TowerLOX® MIS Pedicle Screw System is NKB.

Other records listing Captiva Spine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemK181229TirboLOX-C Cervical IBFDK180990TirboLOX-L Lumbar IBFDK160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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