Merete BLP Small Fragment Locking Bone Plate
FDA 510(k) K063487 · Merete Medical GmbH
510(k) numberK063487
Submission
- Device name
- Merete BLP Small Fragment Locking Bone Plate
- Applicant
- Merete Medical GmbH
Rye, NY, US - Received
- November 17, 2006
- Decision date
- January 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
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| K160548 | MC-Subtalar(TM) IIHWC · Traditional | 04/29/2016SE |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…HWC · Traditional | 02/12/2016SE |
| K151762 | PediatrOS RigidTack/FlexTackJDR · Traditional | 12/28/2015SE |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemHSB · Traditional | 02/09/2015SE |
| K141377 | Bioball Delta Ceramic Heads, Multicup Pe Inlay StandardLZO · Traditional | 11/21/2014SE |
| K140069 | Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS 3.0HRS · Traditional | 04/07/2014SE |
| K132226 | Metafix BLP Plate, Size 31, Left, Metafix BLP Plate, Size 31,RIGHTHRS · Special | 08/09/2013SE |
| K123619 | Intrablock Bioball Hip System (Ibs)LZO · Traditional | 05/24/2013SE |
| K130400 | Meretec CS, Cortical ScrewsHWC · Special | 04/05/2013SE |
| K120787 | Merete Locking Bone Plate System IIIHRS · Traditional | 11/27/2012SE |
Questions and answers
When was Merete BLP Small Fragment Locking Bone Plate cleared by the FDA?
Merete BLP Small Fragment Locking Bone Plate (K063487) received a 510(k) decision of Substantially Equivalent on January 22, 2007, 66 days after the submission was received.
What is the product code of K063487?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.