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FDA 510(k)

TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)

K-Number: K946348 · 1995-08-07

ApplicantSofamor Danek USA,Inc.
Decision Date1995-08-07
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) 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 1995-08-07 under 510(k) number K946348. 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 TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)?

TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K946348.

When did TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) receive FDA 510(k) clearance?

TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) received FDA 510(k) clearance on 1995-08-07, under 510(k) number K946348.

Who is the listed applicant for TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)?

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 TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)?

The FDA product code for TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS) 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 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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