Connexx Locking Tibia Nail
FDA 510(k) K080706 · I.T.S. Implantat-Technologie-Systeme GmbH
510(k) numberK080706
Submission
- Device name
- Connexx Locking Tibia Nail
- Applicant
- I.T.S. Implantat-Technologie-Systeme GmbH
Prior Lake, MN, US - Received
- March 12, 2008
- Decision date
- June 9, 2008
- 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 |
|---|---|---|
| K093868 | I.T.S. LRS Locking Reconstruction SystemHRS · Traditional | 08/05/2010SE |
| K080184 | Distal Humeral Plates with Angular StabilityHRS · Traditional | 03/26/2008SE |
| K063672 | Fibula Plate Prolock with Angular StabilityHRS · Traditional | 02/02/2007SE |
| K063166 | I.T.S. Pelvic Reconstruction SystemHRS · Traditional | 12/22/2006SE |
| K060156 | Straight Plate with Angular Stability & Screw SystemHRS · Traditional | 03/20/2006SE |
| K052368 | Olecranonplate with Angular StabilityHRS · Traditional | 10/17/2005SE |
| K051642 | Fr.O.H. Calcaneus Repair SystemNDF · Traditional | 08/22/2005SE |
| K052011 | Pilonplate with Angular StabilityHRS · Traditional | 08/10/2005SE |
| K051412 | Humeral Head Plate with Angular StabilityHRS · Traditional | 07/11/2005SE |
| K050852 | Claviculaplate with Angular Stablity Bone Plate SystemHRS · Traditional | 06/22/2005SE |
Questions and answers
When was Connexx Locking Tibia Nail cleared by the FDA?
Connexx Locking Tibia Nail (K080706) received a 510(k) decision of Substantially Equivalent on June 9, 2008, 89 days after the submission was received.
What is the product code of K080706?
The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.