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510(k) K903713

OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 by Micro-Aire Surgical Instruments, Inc. — Product Code HSZ

K903713 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229". The FDA issued a decision of Substantially Equivalent on September 14, 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-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1990
Date Received
August 14, 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-Aire Surgical Instruments, Inc.

  • K904949 — A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS (November 26, 1990)
  • K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS (September 14, 1990)
  • K903650 — OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 (September 14, 1990)
  • K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL (September 13, 1990)
  • K901967 — DENDIA WERK BURS AND CUTTING DISCS (July 13, 1990)
  • K901735 — ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 (June 20, 1990)
  • K902168 — ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) (June 20, 1990)
  • K900033 — MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS (February 13, 1990)
  • K900210 — BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 (February 2, 1990)
  • K896280 — MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 (November 22, 1989)

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