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FDA 510(k)

BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020

K-Number: K061162 · 2006-07-26

ApplicantApplied Spine Technologies, Inc.
Decision Date2006-07-26
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Spine Technologies, Inc.. It received FDA 510(k) clearance on 2006-07-26 under 510(k) number K061162. 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 BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020?

BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 is a medical device that received FDA 510(k) clearance on 2006-07-26. The listed applicant is Applied Spine Technologies, Inc.. The 510(k) number is K061162.

When did BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 receive FDA 510(k) clearance?

BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 received FDA 510(k) clearance on 2006-07-26, under 510(k) number K061162.

Who is the listed applicant for BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020?

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

What is the FDA product code for BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020?

The FDA product code for BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 is MNH. This falls under the ENT category.

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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

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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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