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FDA 510(k)

AMSET R-F SYSTEM

K-Number: K951266 · 1995-11-21

ApplicantAdvanced Spine Technology, Inc.
Decision Date1995-11-21
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

AMSET R-F SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Spine Technology, Inc.. It received FDA 510(k) clearance on 1995-11-21 under 510(k) number K951266. 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 AMSET R-F SYSTEM?

AMSET R-F SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-21. The listed applicant is Advanced Spine Technology, Inc.. The 510(k) number is K951266.

When did AMSET R-F SYSTEM receive FDA 510(k) clearance?

AMSET R-F SYSTEM received FDA 510(k) clearance on 1995-11-21, under 510(k) number K951266.

Who is the listed applicant for AMSET R-F SYSTEM?

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

What is the FDA product code for AMSET R-F SYSTEM?

The FDA product code for AMSET R-F SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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Other records listing Advanced Spine Technology, 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.

K062686UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEMK993066WINDOW CERVICAL DYNAMIC PLATE SYSTEMK992147TRIPLE-FIX SPINAL FIXATION SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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