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FDA 510(k)

DANEK PLATE AND SCREW SYSTEM

K-Number: K991036 · 1999-09-14

ApplicantSofamor Danek USA,Inc.
Decision Date1999-09-14
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DANEK PLATE AND SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1999-09-14 under 510(k) number K991036. 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 DANEK PLATE AND SCREW SYSTEM?

DANEK PLATE AND SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-14. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K991036.

When did DANEK PLATE AND SCREW SYSTEM receive FDA 510(k) clearance?

DANEK PLATE AND SCREW SYSTEM received FDA 510(k) clearance on 1999-09-14, under 510(k) number K991036.

Who is the listed applicant for DANEK PLATE AND SCREW SYSTEM?

The FDA 510(k) record lists Sofamor Danek USA,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DANEK PLATE AND SCREW SYSTEM?

The FDA product code for DANEK PLATE AND SCREW SYSTEM is MNH. This falls under the ENT category.

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Other records listing Sofamor Danek USA,Inc. as applicant

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K991031COLORADO II SPINAL SYSTEMK984360COLORADO II SPINAL SYSTEMK992928CD HORIZON SPINAL SYSTEMK991198DYNA-LOK PLUS SPINAL SYSTEMK991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATESK981676CD HORIZON SPINAL SYSTEM

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Related Devices (Code: MNH)

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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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