Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Geister retractor for neuro - and spine surgery

K-Number: K180610 · 2018-08-29

ApplicantGeister Medizin Technik GmbH
Decision Date2018-08-29
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Geister retractor for neuro - and spine surgery is a medical device manufactured by Geister Medizin Technik GmbH. It received FDA 510(k) clearance on 2018-08-29 under approval 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. It is manufactured by Geister Medizin Technik GmbH. The 510(k) number is K180610.

When was Geister retractor for neuro - and spine surgery approved by the FDA?

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

What company makes Geister retractor for neuro - and spine surgery?

Geister retractor for neuro - and spine surgery is manufactured by Geister Medizin Technik GmbH.

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.

Related Clinical Trials

NCT07608276 Impact of NOL - Nociception Level Index Intraoperative Monitoring on Perioperative Outcomes in Spine Surgery - a Quality Improvement Pilot NOT_YET_RECRUITING NCT06525896 Non-surgical Spinal Decompression Therapy and Outcomes ACTIVE_NOT_RECRUITING NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT06827795 An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr) RECRUITING

Other Devices by Geister Medizin Technik GmbH

K242759Geister K-Rex rongeurs

Related Devices (Code: GZT)

K161004Self-retaining RetractorFetzer Medical GmbH & Co. KG K172433NICO BrainPathNico Corporation K161680MEDICON Spinal Spreading SystemsMedicon EG K161318Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding SystemsTedan Surgical Innovations, LLC K202072MindsEye Expandable PortMinnetronix Neuro, Inc. K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.

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.

↑