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510(k) K942603

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

K942603 is an FDA 510(k) premarket notification submitted by Acu Med, Inc. for the device "ORTHOPAEDIC WIRES". The FDA issued a decision of Substantially Equivalent on November 9, 1994. The device falls under product code LRN (Wire, Surgical), a Class II device regulated under 21 CFR 888.3030. Acu Med, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K021321 — WRIST FUSION PLATE (July 17, 2002)
  • K013616 — POLARUS CAP SCREW (December 19, 2001)
  • K012655 — CONGRUENT BONE PLATE SYSTEM (November 7, 2001)
  • 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)

FDA data resources