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FDA 510(k)

AUGMENT-T POSTERIOR SPINAL SYSTEM

K-Number: K950717 · 1996-02-14

ApplicantSofamor Danek USA,Inc.
Decision Date1996-02-14
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

AUGMENT-T POSTERIOR SPINAL 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 1996-02-14 under 510(k) number K950717. 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 AUGMENT-T POSTERIOR SPINAL SYSTEM?

AUGMENT-T POSTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-14. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K950717.

When did AUGMENT-T POSTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

AUGMENT-T POSTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 1996-02-14, under 510(k) number K950717.

Who is the listed applicant for AUGMENT-T POSTERIOR SPINAL 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 AUGMENT-T POSTERIOR SPINAL SYSTEM?

The FDA product code for AUGMENT-T POSTERIOR SPINAL SYSTEM is MNH. This falls under the ENT category.

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Other records listing Sofamor Danek USA,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.

K991031COLORADO II SPINAL SYSTEMK984360COLORADO II SPINAL SYSTEMK992928CD HORIZON SPINAL SYSTEMK991036DANEK PLATE AND SCREW SYSTEMK991198DYNA-LOK PLUS SPINAL SYSTEMK991364MODIFICATION TO TENOR SPINAL SYSTEM-PLATES

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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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