HTO · Class I · 21 CFR 888.4540

FDA Product Code HTO: Reamer

Leading manufacturers include Synthes (Usa), Depuy, Inc. and 3M Company.

14
Total
14
Cleared
56d
Avg days
1977
Since

FDA 510(k) Cleared Reamer Devices (Product Code HTO)

14 devices
1–14 of 14
Cleared Mar 16, 2005
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
K042899
Synthes (Usa)
Orthopedic · 147d
Cleared Dec 21, 2001
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527
Synthes (Usa)
Orthopedic · 59d
Cleared Jun 12, 2000
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
K993335
Synthes (Usa)
Orthopedic · 252d
Cleared Dec 28, 1995
FLEXIBLE INTRAMEDULLARY REAMER
K954915
Zimmer, Inc.
Orthopedic · 63d
Cleared Jun 27, 1979
C.C.F. FEMORAL DEBRIDEMENT PROBE
K790996
Depuy, Inc.
Orthopedic · 29d
Cleared Feb 22, 1979
FLEXIBLE REAMER, GUIDE WIRE SYSTEM
K790307
3M Company
Orthopedic · 9d
Cleared Feb 08, 1977
HAND REAMERS
K770203
Depuy, Inc.
Orthopedic · 8d

About Product Code HTO - Regulatory Context