Cleared Traditional

K181921 - Solidity Vertebral Body Replacement (FDA 510(k) Clearance)

K181921 · Ulrich Medical USA · Orthopedic device

Nov 2018

Decision

121d

Days

Class 2

Risk

K181921 is an FDA 510(k) clearance for the Solidity Vertebral Body Replacement. This device is classified as a Spinal Vertebral Body Replacement Device (Class II - Special Controls, product code MQP).

Submitted by Ulrich Medical USA (Chesterfield, US). The FDA issued a Cleared decision on November 16, 2018, 121 days after receiving the submission on July 18, 2018.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K181921 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 18, 2018
Decision Date	November 16, 2018
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF