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FDA 510(k)

TSRH SPINAL SCREWS

K-Number: K932029 · 1995-01-20

ApplicantSofamor Danek Mfg., Inc.
Decision Date1995-01-20
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TSRH SPINAL SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek Mfg., Inc.. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K932029. 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 TSRH SPINAL SCREWS?

TSRH SPINAL SCREWS is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K932029.

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

TSRH SPINAL SCREWS received FDA 510(k) clearance on 1995-01-20, under 510(k) number K932029.

Who is the listed applicant for TSRH SPINAL SCREWS?

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

What is the FDA product code for TSRH SPINAL SCREWS?

The FDA product code for TSRH SPINAL SCREWS is MNH. This falls under the ENT category.

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Other records listing Sofamor Danek Mfg., 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.

K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMSK930191DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SYK922486DANEK TISSUE CUTTING AND REMOVAL SYSTEMK930807SENTRY ANTERIOR SPINAL SYSTEMK930710SENTRY POSTERIOR SPINAL SYSTEMK923242CROSSLINK AXIAL AND OFFSET 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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