Merete Medical GmbH

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
25
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0650-2022Class IIMerete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx OnlyJanuary 18, 2022
Z-0437-2021Class IIOsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)September 18, 2020
Z-0435-2021Class IIOsteoBridge Intremedullary Knee Arthrodesis (IKA) nailsSeptember 18, 2020
Z-0436-2021Class IIOsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)September 18, 2020
Z-0438-2021Class IIOsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)September 18, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K160548MC-Subtalar(TM) IIApril 29, 2016
K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, February 12, 2016
K151762PediatrOS RigidTack/FlexTackDecember 28, 2015
K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemFebruary 9, 2015
K141377BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARDNovember 21, 2014
K140069LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0April 7, 2014
K132226METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHTAugust 9, 2013
K123619INTRABLOCK BIOBALL HIP SYSTEM (IBS)May 24, 2013
K130400MERETEC CS, CORTICAL SCREWSApril 5, 2013
K120787MERETE LOCKING BONE PLATE SYSTEM IIINovember 27, 2012
K120978OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLARMay 2, 2012
K113303OSLEOBRIDGE IDSF SPACER CONECTORDecember 9, 2011
K102777TWISTCUT ENDOSORB SCREWSDecember 20, 2010
K102688MERETE LOCKING BONE PLATE SYSTEM IIDecember 3, 2010
K101939OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEMOctober 7, 2010
K100414PROTOE ENDOSORB SMALL HAMMER TOE PINJuly 2, 2010
K091798MERETE COMPRESSION SCREWSSeptember 2, 2009
K090063MERETE LOCKING BONE PLATE SYSTEMApril 22, 2009
K081513MERETE 3.0 AND 3.5 MM LOCKING SCREWSJuly 18, 2008
K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMMay 8, 2008