HSH · Class II · 21 CFR 888.3590

FDA Product Code HSH: Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented)

Leading manufacturers include Advanced Bio-Surfaces, Inc., Sulzer Orthopedics, Inc. and Osteoimplant Technology, Inc..

5
Total
5
Cleared
84d
Avg days
2001
Since

FDA 510(k) Cleared Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) Devices (Product Code HSH)

5 devices
1–5 of 5
Cleared Jan 28, 2008
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
K073233
Advanced Bio-Surfaces, Inc.
Orthopedic · 74d
Cleared Feb 06, 2006
ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
K053094
Advanced Bio-Surfaces, Inc.
Orthopedic · 95d
Cleared Nov 20, 2002
OTI UNICONDULAR INTERPOSITIONAL SPACER
K022779
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jan 04, 2001
UNICONDYLAR INTERPOSITIONAL SPACER
K003269
Sulzer Orthopedics, Inc.
Orthopedic · 78d

About Product Code HSH - Regulatory Context