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510(k) K803284

OSTEO OSCILAIR by Richard'S Medical Equip., Inc. — Product Code HSZ

K803284 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "OSTEO OSCILAIR". The FDA issued a decision of Substantially Equivalent on January 9, 1981. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1981
Date Received
December 30, 1980
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 Richard'S Medical Equip., Inc.

  • K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC (June 16, 1983)
  • K823837 — RMC TOTAL KNEE SYSTEM (March 29, 1983)
  • K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS (March 9, 1983)
  • K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP (March 9, 1983)
  • K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS (March 9, 1983)
  • K823722 — SPECTRON LONG, STRAIGHT FEMORAL PROSTHES (March 8, 1983)
  • K823727 — SPECTRON PRIMARY STEM FEMORAL PROSTHES (March 8, 1983)
  • K830153 — RICHARDS INTRA-ARTICULAR SHAVER BLADES (February 28, 1983)
  • K830154 — COLLES FRACTURE FRAME (February 2, 1983)
  • K823725 — SPECTRON PROTRUSIO CUP (January 21, 1983)

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