Cleared Traditional

K201535 - Cerament Bone Void Filler (FDA 510(k) Clearance)

K201535 · Bonesupport AB · Orthopedic device

Oct 2020

Decision

130d

Days

Class 2

Risk

K201535 is an FDA 510(k) clearance for the Cerament Bone Void Filler. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Bonesupport AB (Lund, SE). The FDA issued a Cleared decision on October 16, 2020, 130 days after receiving the submission on June 8, 2020.

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

Submission Details

510(k) Number	K201535 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 08, 2020
Decision Date	October 16, 2020
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF