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510(k) K905187

BONE RASPS by Micro Surgical Instruments Corp. — Product Code HSZ

K905187 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "BONE RASPS". The FDA issued a decision of Substantially Equivalent on December 19, 1990. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Micro Surgical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1990
Date Received
November 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Micro Surgical Instruments Corp.

  • K931395 — SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM (January 28, 1994)
  • K932492 — IMPLANTOLOGY MODULE, MODEL 2175 (October 5, 1993)
  • K930205 — ELECTRIC WIRE DRIVER, MODEL 2640E (August 2, 1993)
  • K914998 — MICROAIRE(R) FACIAL BONE PLATING SYSTEM (June 2, 1992)
  • K915139 — MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE (February 5, 1992)
  • K914346 — DRILL MODULES MODELS 2116/2117 (November 27, 1991)
  • K913369 — MICRO-AIRE MODEL 2060 (November 1, 1991)
  • K913266 — MICRO-AIRE MODEL 2050E/ELEC HANDPIECE/TROTTLELESS (October 21, 1991)
  • K910175 — FIXATION DEVICES AND BONE PLATE (June 21, 1991)
  • K905383 — 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY (June 18, 1991)

Other clearances for product code HSZ

  • K991588 — EMS SWISS ORTHOCLAST (July 21, 1999)
  • K972860 — CURVTEK TSR SYSTEM (October 31, 1997)
  • K970345 — ALIGNMENT INSTRUMENT (April 29, 1997)
  • K955084 — ASPACH 65,000 (MODIFICATION) (January 17, 1996)
  • K954080 — SODEM HIGH SPEED SYSTEM (October 16, 1995)
  • K944590 — ETHICON DRILL BIT AND DRILL GUIDE (May 11, 1995)
  • K934336 — SPINALPLANE (March 10, 1995)
  • K940276 — FILTER, DIFFUSER (November 16, 1994)
  • K942760 — PNEUMATIC WIRE TENSIONER (September 6, 1994)
  • K941681 — ARTHREX CIRCULAR HARVESTING SAW (August 25, 1994)

FDA data resources