LOD · Class II · 21 CFR 888.3027

FDA Product Code LOD: Bone Cement

Leading manufacturers include DePuy Orthopaedics, Inc., Biomet, Inc. and Heraeus Medical GmbH.

72
Total
72
Cleared
167d
Avg days
2000
Since
72 devices
49–72 of 72
Cleared Dec 19, 2001
GENERATION 4 BONE CEMENT
K993836
Biomet, Inc.
Orthopedic · 768d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943
Exactech, Inc.
Orthopedic · 322d
Cleared Jan 26, 2001
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
K002652
Stryker Corp.
Orthopedic · 154d
Cleared Dec 11, 2000
VERSABOND BONE CEMENT
K001160
Smith & Nephew, Inc.
Orthopedic · 245d