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510(k) K072251

MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM by Merete Medical GmbH — Product Code LZJ

K072251 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM". The FDA issued a decision of Substantially Equivalent on May 8, 2008. The device falls under product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained), a Class U device. Merete Medical GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2008
Date Received
August 13, 2007
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 Merete Medical GmbH

  • K160548 — MC-Subtalar(TM) II (April 29, 2016)
  • K152187 — MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Mer (February 12, 2016)
  • K151762 — PediatrOS RigidTack/FlexTack (December 28, 2015)
  • K142451 — OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod Syste (February 9, 2015)
  • K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD (November 21, 2014)
  • K140069 — LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3. (April 7, 2014)
  • K132226 — METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT (August 9, 2013)
  • K123619 — INTRABLOCK BIOBALL HIP SYSTEM (IBS) (May 24, 2013)
  • K130400 — MERETEC CS, CORTICAL SCREWS (April 5, 2013)
  • K120787 — MERETE LOCKING BONE PLATE SYSTEM III (November 27, 2012)

Other clearances for product code LZJ

  • K132496 — ARTHROSURFACE TOEMOTION (February 26, 2014)
  • K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (December 21, 2010)
  • K950864 — GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (July 31, 1995)
  • 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)

FDA data resources