HSZ · Class I · 21 CFR 878.4820

FDA Product Code HSZ: Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

Leading manufacturers include Micro-Aire Surgical Instruments, Inc., The Anspach Effort, Inc. and Tava Surgical Instruments.

56
Total
56
Cleared
87d
Avg days
1978
Since

FDA 510(k) Cleared Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment Devices (Product Code HSZ)

56 devices
1–24 of 56
Cleared Jul 21, 1999
EMS SWISS ORTHOCLAST
K991588
(Ems Sa) Electro Medical Systems
Orthopedic · 75d
Cleared Oct 31, 1997
CURVTEK TSR SYSTEM
K972860
Biolectron, Inc.
Orthopedic · 88d
Cleared Apr 29, 1997
ALIGNMENT INSTRUMENT
K970345
Richard Wolf Medical Instruments Corp.
Orthopedic · 90d
Cleared Jan 17, 1996
ASPACH 65,000 (MODIFICATION)
K955084
The Anspach Effort, Inc.
Orthopedic · 90d
Cleared Oct 16, 1995
SODEM HIGH SPEED SYSTEM
K954080
Sodem Diffusion SA
Orthopedic · 46d
Cleared May 11, 1995
ETHICON DRILL BIT AND DRILL GUIDE
K944590
Ethicon, Inc.
Orthopedic · 234d
Cleared Mar 10, 1995
SPINALPLANE
K934336
Synvasive Technology, Inc.
Orthopedic · 549d
Cleared Nov 16, 1994
FILTER, DIFFUSER
K940276
Anspach Mfg., Inc.
Orthopedic · 299d
Cleared Sep 06, 1994
PNEUMATIC WIRE TENSIONER
K942760
Smith & Nephew Richards, Inc.
Orthopedic · 85d
Cleared Aug 25, 1994
ARTHREX CIRCULAR HARVESTING SAW
K941681
Arthrex, Inc.
Orthopedic · 142d
Cleared Apr 21, 1994
TAVA WIRE-DRIVER
K935367
Tava Surgical Instruments
Orthopedic · 168d
Cleared Jan 27, 1994
PNEUMATIC WIRE TENSIONER
K934431
Smith & Nephew Richards, Inc.
Orthopedic · 136d
Cleared Oct 27, 1993
THE DE SOUTTER M193 REAMER
K930784
De Soutter Medical, Ltd.
Orthopedic · 253d
Cleared Oct 27, 1993
THE DE SOUTTER M182 DRILL
K930785
De Soutter Medical, Ltd.
Orthopedic · 253d
Cleared Jul 22, 1993
MEDNEXT 1000 BONE DISSECTING SYSTEM
K926547
Mednext, Inc.
Orthopedic · 203d
Cleared Sep 18, 1992
HHI PNEUMATIC ROTARY DRILL
K922661
H&H Instruments
Orthopedic · 107d
Cleared Feb 05, 1992
MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE
K915139
Micro Surgical Instruments Corp.
Orthopedic · 84d
Cleared Jan 13, 1992
M170 PNEUMATICALLY OPERATED OSCILLATING SAW
K914845
Desutter Medical , Ltd.
Orthopedic · 77d
Cleared Nov 13, 1991
JOHNSON AND JOHNSON POWER SYSTEM
K913629
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 90d
Cleared Nov 07, 1991
OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
K913559
Osteo AG
Orthopedic · 90d
Cleared Feb 05, 1991
CUP OUT
K905027
Anspach Mfg., Inc.
Orthopedic · 90d
Cleared Jan 08, 1991
MICRO-AIRE 4220-000 OSCILLATING SAW
K905277
Micro Surgical Instruments Corp.
Orthopedic · 46d
Cleared Dec 19, 1990
BONE RASPS
K905187
Micro Surgical Instruments Corp.
Orthopedic · 30d
Cleared Nov 26, 1990
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 24d

About Product Code HSZ - Regulatory Context