Geister retractor for neuro - and spine surgery
FDA 510(k) K180610 · Geister Medizin Technik GmbH
510(k) numberK180610
Submission
- Device name
- Geister retractor for neuro - and spine surgery
- Applicant
- Geister Medizin Technik GmbH
Tuttlingen, DE - Received
- March 8, 2018
- Decision date
- August 29, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Geister retractor for neuro - and spine surgery cleared by the FDA?
Geister retractor for neuro - and spine surgery (K180610) received a 510(k) decision of Substantially Equivalent on August 29, 2018, 174 days after the submission was received.
What is the product code of K180610?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.