MRI · Class I · 21 CFR 890.3490

FDA Product Code MRI: Orthosis, Truncal/orthosis, Limb

Leading manufacturers include Mopac, Ltd. and R. Thomas Grotz, M.D., Inc..

2
Total
2
Cleared
802d
Avg days
1996
Since

FDA 510(k) Cleared Orthosis, Truncal/orthosis, Limb Devices (Product Code MRI)

2 devices
1–2 of 2
Cleared Nov 03, 1997
STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE
K973031
R. Thomas Grotz, M.D., Inc.
Physical Medicine · 81d
Cleared Sep 30, 1996
ORLAU SWIVEL WALKER
K923880
Mopac, Ltd.
Physical Medicine · 1522d

About Product Code MRI - Regulatory Context