Tapered Compression Pin
FDA 510(k) K051740 · Nexa Orthopedics, Inc.
510(k) numberK051740
Submission
- Device name
- Tapered Compression Pin
- Applicant
- Nexa Orthopedics, Inc.
Vista, CA, US - Received
- June 28, 2005
- Decision date
- September 6, 2005
- 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 |
More from Eisertech, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K072710 | Nexfix Compression PinJDW · Traditional | 11/08/2007SE |
| K071147 | Nexa Orthopedics Total Shoulder SystemKWT · Traditional | 07/20/2007SE |
| K070688 | Nexfix Compression StapleJDR · Traditional | 05/18/2007SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | 05/10/2006SE |
| K060071 | Nexa Compression ScrewHWC · Traditional | 01/26/2006SE |
| K053408 | Nexa Bone Plate and Screw SystemHRS · Traditional | 12/22/2005SE |
| K053394 | Nexa Bone Screw SystemHWC · Traditional | 12/14/2005SE |
| K051406 | Osteocure Resorbable Bead KitMQV · Traditional | 08/01/2005SE |
| K033046 | Subtalar Peg ImplantMJW · Traditional | 12/23/2003SE |
| K032902 | Subtalar Arthrorisis ImplantHWC · Traditional | 12/15/2003SE |
Questions and answers
When was Tapered Compression Pin cleared by the FDA?
Tapered Compression Pin (K051740) received a 510(k) decision of Substantially Equivalent on September 6, 2005, 70 days after the submission was received.
What is the product code of K051740?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.