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510(k) K823396

FREE FLEX HEEL HEIGHT ADJUSTOR by Orthopedic Systems, Inc. — Product Code ISH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1982
Date Received
November 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, External, Limb, Ankle/Foot
Device Class
Class I
Regulation Number
890.3420
Review Panel
PM
Submission Type

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  • K890331 — FREEMAN TOTAL HIP SYSTEM RIDGED STEM (October 13, 1989)
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Other clearances for product code ISH

  • K051256 — SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (July 21, 2005)
  • K820505 — ANKLE/FOOT EXTERNAL (March 8, 1982)
  • K791331 — THE TUCKER-SACH FOOT AND TUCKER-SYME FT (August 3, 1979)