The Uni-Clip Staple
FDA 510(k) K011716 · New Deal, S.A.
510(k) numberK011716
Submission
- Device name
- The Uni-Clip Staple
- Applicant
- New Deal, S.A.
Potomac, MD, US - Received
- June 4, 2001
- Decision date
- August 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| K070241 | Modification to Lapidus PlateHRS · Special | 02/08/2007SE |
| K070160 | Modification to TTC PlatesHRS · Special | 02/08/2007SE |
| K063820 | Lisfranc PlateHRS · Special | 02/08/2007SE |
| K060474 | Lisfranc PlateHRS · Traditional | 08/03/2006SE |
| K061765 | Kalix II ImplantHWC · Special | 07/18/2006SE |
| K061594 | Large Uni-Clip StapleJDR · Special | 07/03/2006SE |
| K060476 | Lapidus PlateHRS · Traditional | 05/17/2006SE |
| K060473 | TTC PlateHRS · Traditional | 05/17/2006SE |
| K053093 | Kalix II Implant, Model 141 0XX with XXHWC · Special | 12/07/2005SE |
| K052152 | B-Bop PlateHRS · Traditional | 09/13/2005SE |
Questions and answers
When was The Uni-Clip Staple cleared by the FDA?
The Uni-Clip Staple (K011716) received a 510(k) decision of Substantially Equivalent on August 30, 2001, 87 days after the submission was received.
What is the product code of K011716?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.