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510(k) K823811

OVERHEAD ARM SLINGS by Danek Medical, Inc. — Product Code ILE

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
Sling, Arm, Overhead Supported
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

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  • K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR (May 28, 1999)
  • 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 ILE

  • K830842 — OB HELP ARM (April 5, 1983)
  • K823152 — OB HELP ARM (November 5, 1982)