Company ยท DE
Merete Medical GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2016. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 9 |
| HWC | Screw, Fixation, Bone | 7 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 |
| HRS | Plate, Fixation, Bone | 3 |
| JDR | Staple, Fixation, Bone | 2 |
| JDW | Pin, Fixation, Threaded | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2016 | K160548 | MC-Subtalar(TM) II Merete Medical GmbH, DE | HWC |
| Feb 12, 2016 | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Scre Merete Medical GmbH, DE | HWC |
| Dec 28, 2015 | K151762 | PediatrOS RigidTack/FlexTack Merete Medical GmbH, DE | JDR |
| Feb 9, 2015 | K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System Merete Medical GmbH, DE | HSB |
| Nov 21, 2014 | K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD Merete Medical GmbH, DE | LZO |
| Apr 7, 2014 | K140069 | LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 Merete Medical GmbH, DE | HRS |
| Aug 9, 2013 | K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT Merete Medical GmbH, DE | HRS |
| May 24, 2013 | K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) Merete Medical GmbH, DE | LZO |
| Apr 5, 2013 | K130400 | MERETEC CS, CORTICAL SCREWS Merete Medical GmbH, DE | HWC |
| Nov 27, 2012 | K120787 | MERETE LOCKING BONE PLATE SYSTEM III Merete Medical GmbH | HRS |
| May 2, 2012 | K120978 | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR Merete Medical GmbH, DE | HSB |
| Dec 9, 2011 | K113303 | OSLEOBRIDGE IDSF SPACER CONECTOR Merete Medical GmbH, DE | HSB |
| Dec 20, 2010 | K102777 | TWISTCUT ENDOSORB SCREWS Merete Medical GmbH, DE | JDW |
| Dec 3, 2010 | K102688 | MERETE LOCKING BONE PLATE SYSTEM II Merete Medical GmbH | KTT |
| Oct 7, 2010 | K101939 | OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM Merete Medical GmbH | HSB |
| Jul 2, 2010 | K100414 | PROTOE ENDOSORB SMALL HAMMER TOE PIN Merete Medical GmbH, DE | JDW |
| Sep 2, 2009 | K091798 | MERETE COMPRESSION SCREWS Merete Medical GmbH | HWC |
| Apr 22, 2009 | K090063 | MERETE LOCKING BONE PLATE SYSTEM Merete Medical, Inc. | KTT |
| Jul 18, 2008 | K081513 | MERETE 3.0 AND 3.5 MM LOCKING SCREWS Merete Medical GmbH | HWC |
| May 8, 2008 | K072251 | MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM Merete Medical GmbH | LZJ |
| Jan 22, 2007 | K063487 | MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE Merete Medical GmbH | KTT |
| Jun 16, 2006 | K051965 | OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM Merete Medical GmbH | HSB |
| Jul 7, 2005 | K051323 | MERETE TWISTCUT SNAP-OFF BONE SCREW Merete Medical GmbH | HWC |
| May 27, 2005 | K050924 | MERETE DUOTHREADTM BONE SCREW Merete Medical GmbH | HWC |
| Mar 14, 2005 | K050457 | MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM Merete Medical GmbH | KTT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2022 | Merete Medical GmbH Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only Terminated |
JDR | K151762 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) Terminated |
HSB | K181026 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) Terminated |
HSB | K181026 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) Terminated |
HSB | K181026 |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails Terminated |
HSB | K101939 |