Protoe Endosorb Small Hammer Toe Pin
FDA 510(k) K100414 · Merete Medical GmbH
510(k) numberK100414
Submission
- Device name
- Protoe Endosorb Small Hammer Toe Pin
- Applicant
- Merete Medical GmbH
Berlin, DE - Received
- February 16, 2010
- Decision date
- July 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
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| 510(k) | Device | Decision |
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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 Protoe Endosorb Small Hammer Toe Pin cleared by the FDA?
Protoe Endosorb Small Hammer Toe Pin (K100414) received a 510(k) decision of Substantially Equivalent on July 2, 2010, 136 days after the submission was received.
What is the product code of K100414?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.