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FDA 510(k)

UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM

K-Number: K943725 · 1995-08-25

ApplicantSynthes Spine
Decision Date1995-08-25
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K943725. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM?

UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Synthes Spine. The 510(k) number is K943725.

When did UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM receive FDA 510(k) clearance?

UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM received FDA 510(k) clearance on 1995-08-25, under 510(k) number K943725.

Who is the listed applicant for UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM?

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

What is the FDA product code for UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM?

The FDA product code for UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM is KWQ.

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Other records listing Synthes Spine 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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