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)

Z-Span Plate System

K-Number: K202624 · 2020-11-04

ApplicantZavation Medical Products, LLC
Decision Date2020-11-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Z-Span Plate System is a medical device manufactured by Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2020-11-04 under approval number K202624. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z-Span Plate System?

Z-Span Plate System is a medical device that received FDA 510(k) clearance on 2020-11-04. It is manufactured by Zavation Medical Products, LLC. The 510(k) number is K202624.

When was Z-Span Plate System approved by the FDA?

Z-Span Plate System received FDA 510(k) clearance on 2020-11-04, under approval number K202624.

What company makes Z-Span Plate System?

Z-Span Plate System is manufactured by Zavation Medical Products, LLC.

What is the FDA product code for Z-Span Plate System?

The FDA product code for Z-Span Plate System is KWQ.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Zavation Medical Products, LLC

K180076Ti 3Z Interbody System K180673Normandy VBR System K181246Zavation IBF System K181244Zavation Cervical Plate System K180537Zavation Buttress Plate System K173752SI Screw System

View all 30 devices →

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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.

↑