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510(k) K991588

EMS SWISS ORTHOCLAST by (Ems Sa) Electro Medical Systems — Product Code HSZ

K991588 is an FDA 510(k) premarket notification submitted by (Ems Sa) Electro Medical Systems for the device "EMS SWISS ORTHOCLAST". The FDA issued a decision of Substantially Equivalent on July 21, 1999. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. (Ems Sa) Electro Medical Systems has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1999
Date Received
May 7, 1999
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 (Ems Sa) Electro Medical Systems

  • K073284 — AIR-FLOW MASTER STANDARD (December 14, 2007)
  • K032099 — SWISS MASTER LIGHT (October 27, 2003)
  • K992504 — EMS KERMIT (January 27, 2000)
  • K991874 — EMS SURFACE MOUNT SCALER (July 30, 1999)

Other clearances for product code HSZ

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

FDA data resources