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FDA 510(k)

POLYAXIAL HEMISPHERICAL SPINAL SCREWS

K-Number: K051063 · 2005-05-23

ApplicantScient'X
Decision Date2005-05-23
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLYAXIAL HEMISPHERICAL SPINAL SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X. It received FDA 510(k) clearance on 2005-05-23 under 510(k) number K051063. 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 POLYAXIAL HEMISPHERICAL SPINAL SCREWS?

POLYAXIAL HEMISPHERICAL SPINAL SCREWS is a medical device that received FDA 510(k) clearance on 2005-05-23. The listed applicant is Scient'X. The 510(k) number is K051063.

When did POLYAXIAL HEMISPHERICAL SPINAL SCREWS receive FDA 510(k) clearance?

POLYAXIAL HEMISPHERICAL SPINAL SCREWS received FDA 510(k) clearance on 2005-05-23, under 510(k) number K051063.

Who is the listed applicant for POLYAXIAL HEMISPHERICAL SPINAL SCREWS?

The FDA 510(k) record lists Scient'X as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYAXIAL HEMISPHERICAL SPINAL SCREWS?

The FDA product code for POLYAXIAL HEMISPHERICAL SPINAL SCREWS is MNI.

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Other records listing Scient'X 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.

K071261ISOBAR SEMI-RIGID DUAL DAMPENERK062912SCIENT'X SPINAL SYSTEMK052763STELLA CERVICAL PLATEK052367SCIENT'X CEMENT RESTRICTORK050348CO VERTEBRAL BODY REPLACEMENTK043001MX POLYAXIAL PEDICLE SCREW

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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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