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510(k) K954080

SODEM HIGH SPEED SYSTEM by Sodem Diffusion SA — Product Code HSZ

K954080 is an FDA 510(k) premarket notification submitted by Sodem Diffusion SA for the device "SODEM HIGH SPEED SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 1995. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Sodem Diffusion SA has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1995
Date Received
August 31, 1995
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 Sodem Diffusion SA

  • K954717 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY (January 22, 1997)
  • K955174 — SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (January 22, 1996)

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)
  • 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)
  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)

FDA data resources