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FDA 510(k)

CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM

K-Number: K111115 · 2011-09-13

ApplicantCaptiva Spine, Inc.
Decision Date2011-09-13
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPTIVA SPINE CAPLOX II SPINAL FIXATION 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 2011-09-13 under 510(k) number K111115. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM?

CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is Captiva Spine, Inc.. The 510(k) number is K111115.

When did CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2011-09-13, under 510(k) number K111115.

Who is the listed applicant for CAPTIVA SPINE CAPLOX II SPINAL FIXATION 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 CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM?

The FDA product code for CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM is MNI.

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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 IBFDK180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemK120292CAPLOX II PEDICLE SCREW SYSTEMK110585CAPTIVA SPINE FUSELOX CERVICAL CAGE

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Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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