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FDA 510(k)

SELBY INSTRUMENTATION

K-Number: K945064 · 1995-04-26

ApplicantAdvanced Spine Fixation Systems, Inc.
Decision Date1995-04-26
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELBY INSTRUMENTATION 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 1995-04-26 under 510(k) number K945064. 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 SELBY INSTRUMENTATION?

SELBY INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1995-04-26. The listed applicant is Advanced Spine Fixation Systems, Inc.. The 510(k) number is K945064.

When did SELBY INSTRUMENTATION receive FDA 510(k) clearance?

SELBY INSTRUMENTATION received FDA 510(k) clearance on 1995-04-26, under 510(k) number K945064.

Who is the listed applicant for SELBY INSTRUMENTATION?

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 SELBY INSTRUMENTATION?

The FDA product code for SELBY INSTRUMENTATION is MNH. This falls under the ENT category.

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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 SYSTEMK953779SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEMK953778SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEMK953369STAINLESS STEEL VARIFIX SYSTEM 5.0MM 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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