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FDA 510(k)

Reliance Spinal Screw System

K-Number: K162066 · 2016-12-02

ApplicantReliance Medical Systems, LLC
Decision Date2016-12-02
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reliance Spinal Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K162066. 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 Reliance Spinal Screw System?

Reliance Spinal Screw System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K162066.

When did Reliance Spinal Screw System receive FDA 510(k) clearance?

Reliance Spinal Screw System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K162066.

Who is the listed applicant for Reliance Spinal Screw System?

The FDA 510(k) record lists Reliance Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reliance Spinal Screw System?

The FDA product code for Reliance Spinal Screw System is MNH. This falls under the ENT category.

Other records listing Reliance Medical Systems, LLC 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.

K202266Reliance Cervical IBF SystemK210874Reliance Spinal Screw SystemK183049Reliance Lumbar IBF SystemK181118Reliance Lumbar IBF SystemK180687Reliance Lumber IBF SystemK173283Reliance Lumbar IBF System

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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.

K162801CastleLoc 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.K153404Zavation Spinal SystemZavation, 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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