Cleared Traditional

K200752 - DB-Orthopedics (FDA 510(k) Clearance)

K200752 · Dimensional Bioceramics, LLC · Orthopedic device

Apr 2020

Decision

30d

Days

Class 2

Risk

K200752 is an FDA 510(k) clearance for the DB-Orthopedics. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Dimensional Bioceramics, LLC (Santa Cruz, US). The FDA issued a Cleared decision on April 22, 2020, 30 days after receiving the submission on March 23, 2020.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K200752 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 23, 2020
Decision Date	April 22, 2020
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF