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 American Sterilizer Co..

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 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 May 11, 1995
ETHICON DRILL BIT AND DRILL GUIDE
K944590
Ethicon, Inc.
Orthopedic · 234d
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 Jan 27, 1994
PNEUMATIC WIRE TENSIONER
K934431
Smith & Nephew Richards, Inc.
Orthopedic · 136d
Cleared Nov 26, 1990
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 24d
Cleared Sep 14, 1990
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
K903713
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 31d
Cleared May 14, 1990
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
K901455
Kirschner Medical Corp.
Orthopedic · 42d
Cleared Feb 02, 1990
BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
K900210
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 16d
Cleared Sep 11, 1989
INTERMEDICS POWER BROACH IMPACTOR
K895121
Intermedics Orthopedics
Orthopedic · 27d
Cleared Nov 09, 1988
CONCEPT POWER SYSTEM
K881954
Concept, Inc.
Orthopedic · 183d
Cleared May 04, 1988
ARTUS DISPOSABLE SHEATHS/CUTTERS
K880881
Acufex Microsurgical, Inc.
Orthopedic · 63d
Cleared Apr 15, 1988
ACE PNEUMATIC OSCILLATING SAW
K881250
Buckman Co., Inc.
Orthopedic · 23d
Cleared Feb 17, 1988
MICRO-AIRE CEMENT REMOVAL TOOLS
K880324
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 22d
Cleared Jul 21, 1987
1.1 COUPLERS AND 1.2 ADAPTERS
K872550
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 22d
Cleared Jun 05, 1987
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
K871891
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 21d
Cleared Apr 15, 1987
ORTHOPEDIC DRILL GUIDE
K871287
Orthopedic Systems, Inc.
Orthopedic · 15d
Cleared Nov 19, 1986
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314
The Anspach Effort, Inc.
Orthopedic · 16d
Cleared Apr 25, 1986
REPLACEMENT HOSES
K861405
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 10d
Cleared May 03, 1985
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
K851443
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 22d
Cleared Mar 21, 1985
ACUFEX ARTHROSCOPIC SHAVER
K844130
Acufex Microsurgical, Inc.
Orthopedic · 149d
Cleared Apr 04, 1984
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831
Cabot Medical Corp.
Orthopedic · 40d
Cleared Sep 29, 1983
ANSPACH 65,000
K831756
The Anspach Effort, Inc.
Orthopedic · 120d

About Product Code HSZ - Regulatory Context