Part 888 Subpart B—Diagnostic Devices

FDA submissions for Part 888 Subpart B—Diagnostic Devices in the Orthopedic (OR) review panel, including product codes and regulations.

Section range: §§ 888.1100–888.1600

CFR Part: 888

Product Codes

Product CodeDevice NameRegulationClassDevices
HRXArthroscope888.11002681
NBHAccessories, Arthroscopic888.110012
NGRTester, Stiffness, Cartilage, Arthroscopic888.110022
PPRSurgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures888.110020
LBBDynamometer, Ac-Powered888.1240236
HRWDynamometer, Nonpowered888.1250112
KQXGoniometer, Ac-Powered888.1500133
NKIGoniometer With Electrodes888.150021
KQWGoniometer, Nonpowered888.1520113
LZEIsometer888.152011
QGQBone Indentation Device888.160023
Innolitics

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