Data / Medical devices / Germany / Merete GMBH
Merete GMBH: FDA-registered device maker in Berlin, Germany, 16 510(k) clearances
Merete GMBH is registered with the FDA (registration 3002949614) in Berlin, Germany. It lists 28 device types. The FDA files 16 510(k) clearances under its listings, the newest dated October 17, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002949614
- Address
- 102 Alt Lankwitz, Berlin, Germany, D-12247
- Owner or operator
- MERETE GMBH (9048847)
- Roles
- Specification developer
- First device listed
- August 24, 2005
- Registered through
- 2026
- Brand names listed
- 3D-Saw Template for Scarf/Chevron Osteotomie, BONE SCREW COUNTERSINK, BONE SCREW RULER, Bending Instrument, BioBall Offset Position Assistant, Bone Clamp for Scarf Osteotomie, Chronoceptor, Double Drill Sleeve and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2018 | K181026 | OsteoBridge IDSF System | HSB | Substantially Equivalent | Merete GmbH | accessdata.fda.gov |
| October 23, 2017 | K172213 | MECRON Cannulated Screw System | HWC | Substantially Equivalent | Merete GmbH | accessdata.fda.gov |
| February 12, 2016 | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws | HWC | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| December 28, 2015 | K151762 | PediatrOS RigidTack/FlexTack | JDR | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| April 5, 2013 | K130400 | MERETEC CS, CORTICAL SCREWS | HWC | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| November 27, 2012 | K120787 | MERETE LOCKING BONE PLATE SYSTEM III | HRS | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| May 2, 2012 | K120978 | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR | HSB | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| December 3, 2010 | K102688 | MERETE LOCKING BONE PLATE SYSTEM II | KTT | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| October 7, 2010 | K101939 | OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM | HSB | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| September 2, 2009 | K091798 | MERETE COMPRESSION SCREWS | HWC | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| April 22, 2009 | K090063 | MERETE LOCKING BONE PLATE SYSTEM | KTT | Substantially Equivalent | Merete Medical, Inc. | accessdata.fda.gov |
| July 18, 2008 | K081513 | MERETE 3.0 AND 3.5 MM LOCKING SCREWS | HWC | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| January 22, 2007 | K063487 | MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE | KTT | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| June 16, 2006 | K051965 | OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM | HSB | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| July 7, 2005 | K051323 | MERETE TWISTCUT SNAP-OFF BONE SCREW | HWC | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
| March 14, 2005 | K050457 | MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM | KTT | Substantially Equivalent | Merete Medical GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 18, 2022 | 89482 | Class II | Terminated | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | Incorrect marketing label (25 mm) was applied to product size 20 mm. | accessdata.fda.gov |
| September 18, 2020 | 86526 | Class II | Terminated | OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails | Product may be mislabeled. | accessdata.fda.gov |
Compare with other makers
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- All makers of Wrench
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Updated October 17, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.