Wujin #3 Tibial Nail
FDA 510(k) K002325 · Biologically Oriented Prostheses
510(k) numberK002325
Submission
- Device name
- Wujin #3 Tibial Nail
- Applicant
- Biologically Oriented Prostheses
Port Huron, MI, US - Received
- August 1, 2000
- Decision date
- October 30, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDS – Nail, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | Smith & Nephew, Inc. | 06/12/2025SE |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 09/20/2024SE |
| K241804 | TRIGEN INTERTAN 10S Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 08/22/2024SE |
| K233150 | NET BRAND Osteosynthesis Nailing SystemJDS · Traditional | Narang Medical , Ltd. | 02/20/2024SE |
| K230761 | TRIGEN META-NAIL Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 06/14/2023SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | Synthes (USA) Products, LLC | 09/03/2020SE |
| K192003 | Auxein Nailing SystemJDS · Traditional | Auxein Medical Private Limited | 06/10/2020SE |
| K193533 | WIN Flexible Nail SystemJDS · Traditional | Biomet, Inc. | 02/20/2020SE |
| K141737 | Conventus PHS SystemJDS · Traditional | Conventus Orthopaedics, Inc. | 04/08/2015SE |
| K123948 | China Nails and AccessoriesJDS · Traditional | Smith & Nephew, Inc. | 03/14/2013SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992144 | Biopro Rimmed Acetabular CompomentLZO · Traditional | 09/22/1999SE |
| K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentKYI · Traditional | 02/03/1997SE |
| K962769 | Horizon Hip SystemLPH · Traditional | 10/03/1996SE |
| K955916 | Townley Total Elbow SystemJDC · Traditional | 08/08/1996SE |
| K954768 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 01/18/1996SE |
| K952731 | Townley All Poly Acetabular CupJDI · Traditional | 12/28/1995SE |
| K953045 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 09/27/1995SN |
| K951356 | Various Uhmwp Hip & Knee Joint Prosthesis ModifiedLPH · Traditional | 06/19/1995SN |
Questions and answers
When was Wujin #3 Tibial Nail cleared by the FDA?
Wujin #3 Tibial Nail (K002325) received a 510(k) decision of Substantially Equivalent on October 30, 2000, 90 days after the submission was received.
What is the product code of K002325?
The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.