Product code HSZ— General, Plastic Surgery
MICRO SURGICAL INSTRUMENT SYSTEM
- Classification name
- Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 56
- First cleared
- Most recent
Market context for product code HSZ
FDA has cleared devices under product code HSZ between 1978 and 1999, filed by 35 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 1999
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
Top applicants under product code HSZ
Recent clearances under product code HSZ
- K991588 — EMS SWISS ORTHOCLAST
- K972860 — CURVTEK TSR SYSTEM
- K970345 — ALIGNMENT INSTRUMENT
- K955084 — ASPACH 65,000 (MODIFICATION)
- K954080 — SODEM HIGH SPEED SYSTEM
- K944590 — ETHICON DRILL BIT AND DRILL GUIDE
- K934336 — SPINALPLANE
- K940276 — FILTER, DIFFUSER
- K942760 — PNEUMATIC WIRE TENSIONER
- K941681 — ARTHREX CIRCULAR HARVESTING SAW
- K935367 — TAVA WIRE-DRIVER
- K934431 — PNEUMATIC WIRE TENSIONER
- K930784 — THE DE SOUTTER M193 REAMER
- K930785 — THE DE SOUTTER M182 DRILL
- K926547 — MEDNEXT 1000 BONE DISSECTING SYSTEM
- K922661 — HHI PNEUMATIC ROTARY DRILL
- K915139 — MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE
- K914845 — M170 PNEUMATICALLY OPERATED OSCILLATING SAW
- K913629 — JOHNSON AND JOHNSON POWER SYSTEM
- K913559 — OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
- K905027 — CUP OUT
- K905277 — MICRO-AIRE 4220-000 OSCILLATING SAW
- K905187 — BONE RASPS
- K904949 — A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
- K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
- K901455 — THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
- K900210 — BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
- K885229 — MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
- K895121 — INTERMEDICS POWER BROACH IMPACTOR
- K885273 — MICRO SURGICAL INSTRUMENT SYSTEM
- K884492 — MICRO SURGICAL INSTRUMENT SYSTEM
- K881954 — CONCEPT POWER SYSTEM
- K880881 — ARTUS DISPOSABLE SHEATHS/CUTTERS
- K881250 — ACE PNEUMATIC OSCILLATING SAW
- K880074 — RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
- K880324 — MICRO-AIRE CEMENT REMOVAL TOOLS
- K872550 — 1.1 COUPLERS AND 1.2 ADAPTERS
- K871891 — KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
- K871287 — ORTHOPEDIC DRILL GUIDE
- K864314 — EFTEKHAR RECHANNELIZATION DRILL GUIDE
- K861405 — REPLACEMENT HOSES
- K851443 — MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
- K844130 — ACUFEX ARTHROSCOPIC SHAVER
- K844131 — NUCLEOTOME
- K840831 — ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
- K831756 — ANSPACH 65,000
- K811834 — MICRO OSCILLATING SAW
- K811005 — CORB TM COUNTERROTATING BIOPSY NEEDLE
- K803284 — OSTEO OSCILAIR
- K801329 — ANSPACH INSTRUMENT CADDY
- K800275 — CEBOTOME DRILL
- K791056 — 3M CEMENT REMOVER
- K790645 — ENDOTOME
- K781979 — SURGAIRTOME TWO
- K780139 — PNEUMATIC POWERED BUR
- K772324 — WIREDRIVER
Data sourced from openFDA. This site is unofficial and independent of the FDA.