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FDA 510(k)

SPINAL FORAMINOSCOPE

K-Number: K082841 · 2009-09-09

ApplicantBlazejewski Medi-Tech GmbH
Decision Date2009-09-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL FORAMINOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Blazejewski Medi-Tech GmbH. It received FDA 510(k) clearance on 2009-09-09 under 510(k) number K082841. 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 SPINAL FORAMINOSCOPE?

SPINAL FORAMINOSCOPE is a medical device that received FDA 510(k) clearance on 2009-09-09. The listed applicant is Blazejewski Medi-Tech GmbH. The 510(k) number is K082841.

When did SPINAL FORAMINOSCOPE receive FDA 510(k) clearance?

SPINAL FORAMINOSCOPE received FDA 510(k) clearance on 2009-09-09, under 510(k) number K082841.

Who is the listed applicant for SPINAL FORAMINOSCOPE?

The FDA 510(k) record lists Blazejewski Medi-Tech GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINAL FORAMINOSCOPE?

The FDA product code for SPINAL FORAMINOSCOPE is HRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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