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510(k) K942603

ORTHOPAEDIC WIRES by Acu Med, Inc. — Product Code LRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1994
Date Received
June 1, 1994
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 Acu Med, Inc.

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  • K992525 — ACUMED MODULAR SHOULDER SYSTEM (February 4, 2000)
  • K993657 — ACUMED SUTURE ANCHOR (January 13, 2000)
  • K980103 — ACUMED SUTURE ANCHOR (March 16, 1998)
  • K965028 — ACUMED SUTURE WASHER (March 17, 1997)
  • K965029 — STABLELOC II EXTERNAL FIXATOR (February 19, 1997)
  • K964500 — ACUMED TENSION BAND PIN (December 9, 1996)
  • K963026 — TBD (October 28, 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)
  • K900926 — TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (April 23, 1990)
  • K892651 — SONGER WIRING SYSTEM (July 25, 1989)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)