FDA 510(k)

Geister retractor for neuro - and spine surgery

K-Number: K180610 · 2018-08-29

Decision Date2018-08-29

Product CodeGZT

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Geister retractor for neuro - and spine surgery is the device name listed in this FDA 510(k) record. The listed applicant is Geister Medizin Technik GmbH. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K180610. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geister retractor for neuro - and spine surgery?

Geister retractor for neuro - and spine surgery is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Geister Medizin Technik GmbH. The 510(k) number is K180610.

When did Geister retractor for neuro - and spine surgery receive FDA 510(k) clearance?

Geister retractor for neuro - and spine surgery received FDA 510(k) clearance on 2018-08-29, under 510(k) number K180610.

Who is the listed applicant for Geister retractor for neuro - and spine surgery?

The FDA 510(k) record lists Geister Medizin Technik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Geister retractor for neuro - and spine surgery?

The FDA product code for Geister retractor for neuro - and spine surgery is GZT.

Other records listing Geister Medizin Technik GmbH 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.

K242759Geister K-Rex rongeurs

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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.