FDA 510(k) Premarket Notification K161478: Xenco Medical Posterior Cervical System

Submission Details & Decision

Normalized public record details for 510(k) notification K161478.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K161478

Applicant / Sponsor

Xenco Medical, LLC

Device Name

Xenco Medical Posterior Cervical System

Product Code

NKG

Decision Date

2016-09-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Orthopedic (OR)

Clearance Type

Traditional

Third Party Flag

Date Received

2016-05-31

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