Cleared Traditional

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds

K240856 · Osartis GmbH · Orthopedic
Nov 2024
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K240856 is an FDA 510(k) clearance for the Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds, a Bone Cement, Antibiotic (Class II — Special Controls, product code MBB), submitted by Osartis GmbH (M?nster, DE). The FDA issued a Cleared decision on November 20, 2024, 237 days after receiving the submission on March 28, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K240856 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2024
Decision Date November 20, 2024
Days to Decision 237 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBB — Bone Cement, Antibiotic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027