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510(k) K900210

BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500 by Micro-Aire Surgical Instruments, Inc. — Product Code HSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1990
Date Received
January 17, 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.

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  • K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS (September 14, 1990)
  • K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229 (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)
  • K896280 — MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 (November 22, 1989)

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  • 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)