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510(k) K950864

GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) by Acu Med, Inc. — Product Code LZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
February 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device Class
Class U
Regulation Number
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 LZJ

  • K132496 — ARTHROSURFACE TOEMOTION (February 26, 2014)
  • K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (December 21, 2010)
  • K072251 — MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (May 8, 2008)
  • K941650 — TOTAL TOE SYSTEM II (December 19, 1994)
  • K924724 — KINETIK GREAT TOE SYSTEM (January 5, 1994)
  • K922211 — OSTEOMED GREAT TOE SYSTEM (November 9, 1993)
  • K920446 — TOTAL TOE SYSTEM (March 22, 1993)
  • K920667 — GREAT TOE IMPLANT (June 19, 1992)
  • K911552 — ANATOMIC TOE SYSTEM (June 28, 1991)
  • K884561 — KOENIG TOTAL TOE IMPLANT (January 24, 1989)