Synthes 5.0/7.3 MM Cannulated Locking Screws
FDA 510(k) K040765 · Synthes (Usa)
510(k) numberK040765
Submission
- Device name
- Synthes 5.0/7.3 MM Cannulated Locking Screws
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- March 25, 2004
- Decision date
- April 12, 2004
- 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 |
|---|---|---|
| K180821 | TruMatch Graft Cage - Long BoneHRS · Traditional | 12/21/2018SE |
| K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction SystemKTT · Traditional | 11/10/2016SE |
| K152239 | Zero-P Natural Plate SystemKWQ · Traditional | 12/02/2015SE |
| K141527 | Depuy Synthes Variable Angle Locking Hand SystemHRS · Traditional | 03/30/2015SE |
| K131984 | Synthes Synsonic Ulna NailHSB · Traditional | 03/31/2014SE |
| K130146 | Synthes Synflate Vertevral Balloon SystemNDN · Traditional | 05/20/2013SE |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateHRS · Traditional | 07/06/2012SE |
| K112030 | Synthes Radial Head Prosthesis SystemKWI · Traditional | 06/19/2012SE |
| K120854 | Synthes Va LCP Ankle Trauma SystemHRS · Traditional | 06/18/2012SE |
| K120275 | Synthes Acis/Vertebral Spacer CRODP · Traditional | 05/25/2012SE |
Questions and answers
When was Synthes 5.0/7.3 MM Cannulated Locking Screws cleared by the FDA?
Synthes 5.0/7.3 MM Cannulated Locking Screws (K040765) received a 510(k) decision of Substantially Equivalent on April 12, 2004, 18 days after the submission was received.
What is the product code of K040765?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.