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510(k) K823820

ABDUCTION PILLOW by Danek Medical, Inc. — Product Code IOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 17, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Abduction, Congenital Hip Dislocation
Device Class
Class I
Regulation Number
890.3665
Review Panel
PM
Submission Type

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  • K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM (March 10, 1999)
  • K982875 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (January 19, 1999)
  • K984522 — MODIFICATION OF TSRH SPINAL SYSTEM (January 6, 1999)
  • K982154 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (July 13, 1998)
  • K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM (March 20, 1998)
  • K943827 — SPINE FIXATION (February 14, 1996)

Other clearances for product code IOZ

  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)
  • K780375 — PAVLIK HARNESS (March 15, 1978)