Home / 510(k) Clearances / K892651

510(k) K892651

SONGER WIRING SYSTEM by Danek Medical, Inc. — Product Code LRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1989
Date Received
April 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Surgical
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Danek Medical, Inc.

  • K994122 — BONE GRAFT WASHER, MODEL 9090114 - 9090118 (February 18, 2000)
  • K993810 — CD HORIZON SPINAL SYSTEM (February 3, 2000)
  • K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (December 15, 1999)
  • 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 LRN

  • K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (December 4, 2000)
  • K990355 — STAINLESS STEEL SOFT SUTURE WIRE (July 8, 1999)
  • K971682 — J-FX CERCLAGE SYSTEM (June 27, 1997)
  • K952783 — OXBORO-MEDICAL PIN COVERS (September 15, 1995)
  • K942603 — ORTHOPAEDIC WIRES (November 9, 1994)
  • K900926 — TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (April 23, 1990)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)