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FDA 510(k)

SENTRY ANTERIOR SPINAL SYSTEM

K-Number: K930807 · 1993-10-01

ApplicantSofamor Danek Mfg., Inc.
Decision Date1993-10-01
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SENTRY ANTERIOR SPINAL SYSTEM 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 1993-10-01 under 510(k) number K930807. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTRY ANTERIOR SPINAL SYSTEM?

SENTRY ANTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1993-10-01. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K930807.

When did SENTRY ANTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

SENTRY ANTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 1993-10-01, under 510(k) number K930807.

Who is the listed applicant for SENTRY ANTERIOR SPINAL SYSTEM?

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 SENTRY ANTERIOR SPINAL SYSTEM?

The FDA product code for SENTRY ANTERIOR SPINAL SYSTEM is KWQ.

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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 SYK932029TSRH SPINAL SCREWSK922486DANEK TISSUE CUTTING AND REMOVAL SYSTEMK930710SENTRY POSTERIOR SPINAL SYSTEMK922543Z-PLATE ANTERIOR FIXATION SYSTEM

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Related Devices (Code: KWQ)

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.

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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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