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510(k) K903650

OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305 by Micro-Aire Surgical Instruments, Inc. — Product Code HWE

K903650 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305". The FDA issued a decision of Substantially Equivalent on September 14, 1990. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And 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 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And 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)
  • K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 (September 14, 1990)
  • K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS (September 14, 1990)
  • K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL (September 13, 1990)
  • K901967 — DENDIA WERK BURS AND CUTTING DISCS (July 13, 1990)
  • K902168 — ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS) (June 20, 1990)
  • K901735 — ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 (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 HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)

FDA data resources