Sbi Titanium Threaded Pin
FDA 510(k) K071540 · Small Bone Innovations, Inc.
510(k) numberK071540
Submission
- Device name
- Sbi Titanium Threaded Pin
- Applicant
- Small Bone Innovations, Inc.
New York, NY, US - Received
- June 5, 2007
- Decision date
- August 8, 2007
- 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 |
|---|---|---|
| K130147 | Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)HSB · Special | 05/03/2013SE |
| K112982 | Anatomic Ankle Arthrodesis Interlocking NAIL(A3 Interlocking Nail )HSB · Traditional | 04/02/2012SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | 12/20/2010SE |
| K092754 | Sbi Foot and Ankle Cannulated Screw System, Model 100-0061HWC · Traditional | 01/19/2010SE |
| K093550 | Mini Rail External Fixator SystemKTT · Special | 01/07/2010SE |
| K073635 | Sbi SR MTP Toe ImplantKWD · Traditional | 03/19/2008SE |
| K071541 | Sbi TwistofixHWC · Traditional | 09/10/2007SE |
| K063635 | Sbi Forefoot SetHWC · Traditional | 08/29/2007SE |
| K071656 | Sbi ArtfixHWC · Traditional | 08/27/2007SE |
| K071549 | Sbi Rhead Plating SystemHRS · Traditional | 08/07/2007SE |
Questions and answers
When was Sbi Titanium Threaded Pin cleared by the FDA?
Sbi Titanium Threaded Pin (K071540) received a 510(k) decision of Substantially Equivalent on August 8, 2007, 64 days after the submission was received.
What is the product code of K071540?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.