NuVasive Cohere Thoracolumbar Interbody System

FDA 510(k) Premarket Notification · Submission K193541 · Applicant: Nu Vasive, Incorporated

Public Record 510(k) Submission Decision Date: 2020-03-30 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K193541.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K193541
Applicant / Sponsor
Device Name
NuVasive Cohere Thoracolumbar Interbody System
Product Code
MAX
Decision Date
2020-03-30
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Orthopedic (OR)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2019-12-20

Related Establishments / Registrations

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