Temporary Fixation Pins
FDA 510(k) K192768 · Eisertech, LLC
510(k) numberK192768
Submission
- Device name
- Temporary Fixation Pins
- Applicant
- Eisertech, LLC
San Diego, CA, US - Received
- September 30, 2019
- Decision date
- December 26, 2019
- 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 |
| K182171 | SMV Scientific K-Wire and PinsJDW · Traditional | Summit Medventures | 10/25/2018SE |
More from Summit Medventures
| 510(k) | Device | Decision |
|---|---|---|
| K190565 | Cervical PlateKWQ · Traditional | 05/31/2019SE |
| K140348 | Interbody CageMAX · Traditional | 04/23/2015SE |
| K142576 | Spinal SystemNKB · Traditional | 02/26/2015SE |
| K122444 | Cervical CageODP · Special | 08/30/2012SE |
| K113170 | Cervical PlateKWQ · Traditional | 04/06/2012SE |
| K113478 | Plif CageMAX · Abbreviated | 03/05/2012SE |
| K110915 | Cervical CageODP · Abbreviated | 07/22/2011SE |
Questions and answers
When was Temporary Fixation Pins cleared by the FDA?
Temporary Fixation Pins (K192768) received a 510(k) decision of Substantially Equivalent on December 26, 2019, 87 days after the submission was received.
What is the product code of K192768?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.