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FDA 510(k)

SHIRAZ-JAVA SPINAL FIXATION SYSTEM

K-Number: K031265 · 2003-10-09

ApplicantSpine Next SA
Decision Date2003-10-09
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHIRAZ-JAVA SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Next SA. It received FDA 510(k) clearance on 2003-10-09 under 510(k) number K031265. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIRAZ-JAVA SPINAL FIXATION SYSTEM?

SHIRAZ-JAVA SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-09. The listed applicant is Spine Next SA. The 510(k) number is K031265.

When did SHIRAZ-JAVA SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

SHIRAZ-JAVA SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2003-10-09, under 510(k) number K031265.

Who is the listed applicant for SHIRAZ-JAVA SPINAL FIXATION SYSTEM?

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

What is the FDA product code for SHIRAZ-JAVA SPINAL FIXATION SYSTEM?

The FDA product code for SHIRAZ-JAVA SPINAL FIXATION SYSTEM is MNH. This falls under the ENT category.

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Other records listing Spine Next SA 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.

K030871FIDJI LARGE CEMENT RESTRICTORK030767FIDJI SMALL CEMENT RESTRICTOR

Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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