Mli Modular Staple
FDA 510(k) K962705 · Medicinelodge, Inc.
510(k) numberK962705
Submission
- Device name
- Mli Modular Staple
- Applicant
- Medicinelodge, Inc.
Sacramento, CA, US - Received
- July 12, 1996
- Decision date
- October 1, 1996
- 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 |
|---|---|---|
| K072525 | Zipknot, Model 1017-3000FZP · Special | 10/05/2007SE |
| K051488 | Medicinelodge ZipknotNVH · Traditional | 07/27/2005SE |
| K961920 | Cross PinJDW · Traditional | 09/17/1996SE |
| K961905 | Medicinelodge, Inc. Set ScrewHWC · Traditional | 08/06/1996SE |
| K962194 | Mli Soft Tissue Screw & Washer SystemMBI · Traditional | 07/30/1996SE |
| K961025 | Expanded Body SutureGAT · Traditional | 04/15/1996SN |
| K953350 | Mli Interference ScrewHWC · Traditional | 01/30/1996SN |
Questions and answers
When was Mli Modular Staple cleared by the FDA?
Mli Modular Staple (K962705) received a 510(k) decision of Substantially Equivalent on October 1, 1996, 81 days after the submission was received.
What is the product code of K962705?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.