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510(k) K883457

ASST-3000 SPINAL SURGERY TABLE by Orthopedic Systems, Inc. — Product Code FWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1988
Date Received
August 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Non-Electrical
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

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  • K910736 — JACKSON MULTIPURPOSE OPERATING TABLE (May 21, 1991)
  • K910031 — PARK CITY SHOULDER POSITIONER (January 24, 1991)
  • K903938 — C FIT CUP (January 4, 1991)
  • K892503 — NUFFIELD TOTAL KNEE (May 4, 1990)
  • K896678 — SILICONE PLUG (January 30, 1990)
  • K894283 — COMPREHENSIVE SPINE MOTION ANALYZER (January 19, 1990)
  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)

Other clearances for product code FWY

  • K873478 — SKYTRON MODEL 130 SURGICAL TABLE (September 24, 1987)
  • K833509 — CHEMONUCLEOLYSIS TABLE (November 28, 1983)
  • K800118 — CHICK SURGICAL TABLE (February 5, 1980)