Merete Medical GmbH
FDA Regulatory Profile
Merete Medical GmbH appears in FDA public data with 5 recalls, 25 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0650-2022, Class II) was initiated on January 18, 2022. Its most recent 510(k) clearance was granted on April 29, 2016.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 25
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0650-2022 | Class II | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only | January 18, 2022 |
| Z-0437-2021 | Class II | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) | September 18, 2020 |
| Z-0435-2021 | Class II | OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails | September 18, 2020 |
| Z-0436-2021 | Class II | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) | September 18, 2020 |
| Z-0438-2021 | Class II | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) | September 18, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160548 | MC-Subtalar(TM) II | April 29, 2016 |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, | February 12, 2016 |
| K151762 | PediatrOS RigidTack/FlexTack | December 28, 2015 |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System | 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 3.0 | 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 |
| K120978 | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR | May 2, 2012 |
| K113303 | OSLEOBRIDGE IDSF SPACER CONECTOR | December 9, 2011 |
| K102777 | TWISTCUT ENDOSORB SCREWS | December 20, 2010 |
| K102688 | MERETE LOCKING BONE PLATE SYSTEM II | December 3, 2010 |
| K101939 | OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM | October 7, 2010 |
| K100414 | PROTOE ENDOSORB SMALL HAMMER TOE PIN | July 2, 2010 |
| K091798 | MERETE COMPRESSION SCREWS | September 2, 2009 |
| K090063 | MERETE LOCKING BONE PLATE SYSTEM | April 22, 2009 |
| K081513 | MERETE 3.0 AND 3.5 MM LOCKING SCREWS | July 18, 2008 |
| K072251 | MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM | May 8, 2008 |