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510(k) K913559

OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR by Osteo AG — Product Code HSZ

K913559 is an FDA 510(k) premarket notification submitted by Osteo AG for the device "OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR". The FDA issued a decision of Substantially Equivalent on November 7, 1991. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Osteo AG has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
August 9, 1991
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 Osteo AG

  • K933340 — OSTEO INTERLOCKING-COMPRESSION NAIL (June 30, 1994)
  • K922196 — OSTEO TIBIA NAIL (July 23, 1992)
  • K922195 — OSTEO FEMORAL NAIL (July 23, 1992)
  • K922193 — OSTEO KIRSCHNER WIRE (July 23, 1992)
  • K922194 — OSTEO STEINMANN PIN (July 23, 1992)
  • K920149 — OSTEO EX-FI-RE (April 9, 1992)
  • K920037 — OSTEO COMPRESSION HIP SCREW (March 11, 1992)
  • K914374 — OSTEO CERCLAGE WIRE (December 30, 1991)

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