Femoral Intramedullary Rods
FDA 510(k) K926465 · Applied Osteo Systems, Inc.
510(k) numberK926465
Submission
- Device name
- Femoral Intramedullary Rods
- Applicant
- Applied Osteo Systems, Inc.
Walnut Creek, CA, US - Received
- December 24, 1992
- Decision date
- August 25, 1993
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K935383 | Femrod and Femrod Recon InsertHSB · Traditional | 03/21/1995SE |
| K933995 | True/Flextm Femur Rods, Caps, Screws and InstrumentationHSB · Traditional | 01/27/1995SE |
| K944501 | True/Flex Intramedullary Rod End-CapHSB · Traditional | 11/28/1994SE |
| K941048 | True/Lok Monolateral/Bilateral FixatorLXT · Traditional | 10/03/1994SE |
| K943160 | Interference ScrewHWC · Traditional | 09/30/1994SN |
| K934148 | True/Flex Clavicle RodsHSB · Traditional | 02/22/1994SE |
| K932853 | Pin Holders, Transfixing Pins, Ol Wires, Half PinsJEL · Traditional | 02/22/1994SE |
| K931578 | Texas Scottish Rite Easy/Lock FixatorJEC · Traditional | 02/22/1994SE |
| K924657 | True/Flex Metatarsal RodsKTW · Traditional | 11/24/1992SE |
| K924656 | True/ Flex Fibula RodsHSB · Traditional | 11/24/1992SE |
Questions and answers
When was Femoral Intramedullary Rods cleared by the FDA?
Femoral Intramedullary Rods (K926465) received a 510(k) decision of Substantially Equivalent on August 25, 1993, 244 days after the submission was received.
What is the product code of K926465?
The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.