Scaphix, Staple, Fixation, Bone
FDA 510(k) K003033 · Avanta Orthopaedics, Inc.
510(k) numberK003033
Submission
- Device name
- Scaphix, Staple, Fixation, Bone
- Applicant
- Avanta Orthopaedics, Inc.
San Diego, CA, US - Received
- September 28, 2000
- Decision date
- May 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
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| 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 |
|---|---|---|
| K030881 | Avanta Carpal Fusion Plating SystemHRS · Traditional | 04/10/2003SE |
| K021859 | Wrist ImplantJWJ · Traditional | 12/02/2002SE |
| K023604 | Modification to Radial Head ImplantKWI · Special | 11/27/2002SE |
| K013629 | Finger Joint ProsthesisKYJ · Traditional | 01/25/2002SE |
| K011819 | Radial Head ImplantKWI · Special | 06/19/2001SE |
| K010847 | K'FixNDL · Traditional | 06/19/2001SE |
| K010786 | Ulnar Head ImplantKXE · Special | 04/11/2001SE |
| K002644 | Radial Head ImplantKWI · Traditional | 11/20/2000SE |
| K990596 | Distal Radius Fracture Fixation Plate SystemHRS · Traditional | 04/29/1999SE |
| K982268 | Ulnar Head ImplantKXE · Traditional | 12/04/1998SE |
Questions and answers
When was Scaphix, Staple, Fixation, Bone cleared by the FDA?
Scaphix, Staple, Fixation, Bone (K003033) received a 510(k) decision of Substantially Equivalent on May 30, 2001, 244 days after the submission was received.
What is the product code of K003033?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.