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FDA 510(k)

DANEK TISSUE CUTTING AND REMOVAL SYSTEM

K-Number: K922486 · 1993-10-12

ApplicantSofamor Danek Mfg., Inc.
Decision Date1993-10-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DANEK TISSUE CUTTING AND REMOVAL 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 1993-10-12 under 510(k) number K922486. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DANEK TISSUE CUTTING AND REMOVAL SYSTEM?

DANEK TISSUE CUTTING AND REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Sofamor Danek Mfg., Inc.. The 510(k) number is K922486.

When did DANEK TISSUE CUTTING AND REMOVAL SYSTEM receive FDA 510(k) clearance?

DANEK TISSUE CUTTING AND REMOVAL SYSTEM received FDA 510(k) clearance on 1993-10-12, under 510(k) number K922486.

Who is the listed applicant for DANEK TISSUE CUTTING AND REMOVAL 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 DANEK TISSUE CUTTING AND REMOVAL SYSTEM?

The FDA product code for DANEK TISSUE CUTTING AND REMOVAL SYSTEM is HRX.

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Other records listing Sofamor Danek Mfg., Inc. as applicant

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Related Devices (Code: HRX)

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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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