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FDA 510(k)

CAPLESS PEDICLE SCREW SYSTEM

K-Number: K052847 · 2005-12-12

ApplicantX-Spine Systems, Inc.
Decision Date2005-12-12
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPLESS PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2005-12-12 under 510(k) number K052847. 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 CAPLESS PEDICLE SCREW SYSTEM?

CAPLESS PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-12. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K052847.

When did CAPLESS PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

CAPLESS PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2005-12-12, under 510(k) number K052847.

Who is the listed applicant for CAPLESS PEDICLE SCREW SYSTEM?

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

What is the FDA product code for CAPLESS PEDICLE SCREW SYSTEM?

The FDA product code for CAPLESS PEDICLE SCREW SYSTEM is MNI.

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Other records listing X-Spine Systems, Inc. as applicant

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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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