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FDA 510(k)

SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM

K-Number: K953779 · 1995-11-07

ApplicantAdvanced Spine Fixation Systems, Inc.
Decision Date1995-11-07
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Spine Fixation Systems, Inc.. It received FDA 510(k) clearance on 1995-11-07 under 510(k) number K953779. 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 for Some Indications.

Frequently Asked Questions

What is the SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM?

SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-07. The listed applicant is Advanced Spine Fixation Systems, Inc.. The 510(k) number is K953779.

When did SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM receive FDA 510(k) clearance?

SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM received FDA 510(k) clearance on 1995-11-07, under 510(k) number K953779.

Who is the listed applicant for SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM?

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

What is the FDA product code for SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM?

The FDA product code for SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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Other records listing Advanced Spine Fixation Systems, 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.

K992012WILTSE SYSTEMK990845MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15K954770CENTRA-LINE GRAPPLE, VARIFIX SYSTEMK953778SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEMK953369STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREWK9513085.8MM DIAMETER ANCHOR SCREW

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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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