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FDA 510(k)

DANEK SPINALSCOPE

K-Number: K901692 · 1992-02-14

ApplicantDanek Medical, Inc.
Decision Date1992-02-14
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DANEK SPINALSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1992-02-14 under 510(k) number K901692. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANEK SPINALSCOPE?

DANEK SPINALSCOPE is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Danek Medical, Inc.. The 510(k) number is K901692.

When did DANEK SPINALSCOPE receive FDA 510(k) clearance?

DANEK SPINALSCOPE received FDA 510(k) clearance on 1992-02-14, under 510(k) number K901692.

Who is the listed applicant for DANEK SPINALSCOPE?

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

What is the FDA product code for DANEK SPINALSCOPE?

The FDA product code for DANEK SPINALSCOPE is HRX.

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Other records listing Danek Medical, Inc. as applicant

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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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