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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Merete Medical GmbH — Predicate Candidate Screening

24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

84 daysmedian FDA review time
257 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160548MC-Subtalar(TM) IIMerete Medical GmbH2016-04-29600
K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Merete Medical GmbH2016-02-121910
K151762PediatrOS RigidTack/FlexTackMerete Medical GmbH2015-12-281820
K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental DefecMerete Medical GmbH2015-02-091600
K141377BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARDMerete Medical GmbH2014-11-211780
K140069LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MEREMerete Medical GmbH2014-04-07840
K132226METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31Merete Medical GmbH2013-08-09230
K123619INTRABLOCK BIOBALL HIP SYSTEM (IBS)Merete Medical GmbH2013-05-241820
K130400MERETEC CS, CORTICAL SCREWSMerete Medical GmbH2013-04-05450
K120787MERETE LOCKING BONE PLATE SYSTEM IIIMerete Medical GmbH2012-11-272570
K120978OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLARMerete Medical GmbH2012-05-02300
K113303OSLEOBRIDGE IDSF SPACER CONECTORMerete Medical GmbH2011-12-09300
K102777TWISTCUT ENDOSORB SCREWSMerete Medical GmbH2010-12-20870
K102688MERETE LOCKING BONE PLATE SYSTEM IIMerete Medical GmbH2010-12-03770
K101939OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATIONMerete Medical GmbH2010-10-07870
K100414PROTOE ENDOSORB SMALL HAMMER TOE PINMerete Medical GmbH2010-07-021360
K091798MERETE COMPRESSION SCREWSMerete Medical GmbH2009-09-02770
K081513MERETE 3.0 AND 3.5 MM LOCKING SCREWSMerete Medical GmbH2008-07-18490
K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMMerete Medical GmbH2008-05-082690
K063487MERETE BLP SMALL FRAGMENT LOCKING BONE PLATEMerete Medical GmbH2007-01-22660
K051965OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT Merete Medical GmbH2006-06-163310
K051323MERETE TWISTCUT SNAP-OFF BONE SCREWMerete Medical GmbH2005-07-07480
K050924MERETE DUOTHREADTM BONE SCREWMerete Medical GmbH2005-05-27440
K050457MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEMMerete Medical GmbH2005-03-14190

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda