KIJ · Class I · 21 CFR 878.4820

FDA Product Code KIJ: Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

Leading manufacturers include Dyonics, Inc., Jeil Medical Corporation and Insurgical, LLC.

29
Total
29
Cleared
138d
Avg days
1978
Since

FDA 510(k) Cleared Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment Devices (Product Code KIJ)

29 devices
1–24 of 29
Cleared Dec 27, 2016
SMARTO
K163308
Jeil Medical Corporation
Orthopedic · 34d
Cleared Nov 06, 2012
INSURGICAL SINGLE USE POWER EQUIPMENT
K112599
Insurgical, LLC
Orthopedic · 426d
Cleared Dec 17, 2010
SMARTO
K101563
Jeil Medical Corporation
Orthopedic · 196d
Cleared Sep 04, 1997
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K972367
Stryker Instruments
Orthopedic · 71d
Cleared Apr 30, 1997
STRYKER 2115 REPLACEMENT BATTERY (2115)
K970378
Implant Resource, Inc.
Orthopedic · 89d
Cleared May 07, 1996
ACUMED BONE GRAFT SYSTEM
K960711
Acu Med, Inc.
Orthopedic · 76d
Cleared Nov 14, 1994
ARTHREX GRAFT HARVESTING KIT
K941285
Arthrex, Inc.
Orthopedic · 242d
Cleared Nov 07, 1994
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
K933101
Osteomed Corp.
Orthopedic · 501d
Cleared Apr 05, 1994
R AND D BATTERY REPLACEMENT
K933337
R & D Batteries, Inc.
Orthopedic · 271d
Cleared Jan 07, 1994
3M MAXI-DRIVER II DBATTERY POWERED SYSTEM
K932307
3M Health Care, Ltd.
Orthopedic · 241d
Cleared Dec 07, 1988
MODIFIED SAW BLADES TO THE SAGITAL SAW
K884839
Dyonics, Inc.
Orthopedic · 16d
Cleared Nov 07, 1986
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
K864137
Bio-Rad
Immunology · 17d
Cleared Jun 28, 1985
FLUTED SUCTION MENISCAL CUTTER
K850789
T. Korossurgical Instruments Corp.
Orthopedic · 122d
Cleared Oct 22, 1982
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K822790
Xomed, Inc.
Orthopedic · 37d
Cleared May 07, 1982
INTRA-ARTICULAR SURGICAL SYSTEM
K820367
Dyonics, Inc.
Orthopedic · 87d
Cleared Feb 05, 1979
DRILL, CORDLESS SURGICAL
K790063
Richard'S Medical Equip., Inc.
Orthopedic · 21d
Cleared Feb 01, 1978
INTRA-ARTICULAR SHAVER
K771218
Dyonics, Inc.
Orthopedic · 211d

About Product Code KIJ - Regulatory Context