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510(k) K021502

OSCAR, MODEL OE3000 by Orthosonics, Ltd. — Product Code LZV

K021502 is an FDA 510(k) premarket notification submitted by Orthosonics, Ltd. for the device "OSCAR, MODEL OE3000". The FDA issued a decision of Substantially Equivalent on June 6, 2002. The device falls under product code LZV (System, Cement Removal Extraction), a Class II device regulated under 21 CFR 888.4580. Orthosonics, Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2002
Date Received
May 9, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Cement Removal Extraction
Device Class
Class II
Regulation Number
888.4580
Review Panel
OR
Submission Type

Other clearances by Orthosonics, Ltd.

  • K093805 — OSCAR 3 (February 19, 2010)
  • K083830 — OSCAR BONE RESECTOR (March 20, 2009)
  • K051053 — OSCAR, MODEL OE3000DB (July 21, 2005)

Other clearances for product code LZV

  • K961101 — STRYKER CEMENT REMOVAL SYSTEM (July 15, 1996)
  • K930629 — ACRYL-X II SYSTEM (January 21, 1994)
  • K904156 — ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS (November 27, 1990)
  • K904180 — PROSTHETIC CEMENT REMOVER (November 20, 1990)
  • K891472 — IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR (May 2, 1989)
  • K890285 — PROSTHETIC CEMENT REMOVER (April 19, 1989)

FDA data resources