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510(k) K915139

MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE by Micro Surgical Instruments Corp. — Product Code HSZ

K915139 is an FDA 510(k) premarket notification submitted by Micro Surgical Instruments Corp. for the device "MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE". The FDA issued a decision of Substantially Equivalent on February 5, 1992. 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
February 5, 1992
Date Received
November 13, 1991
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)
  • 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)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 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