Reverto 55 and 37 Shape Memory Staples
FDA 510(k) K071477 · Core Essence Orthopaedics, LLC
510(k) numberK071477
Submission
- Device name
- Reverto 55 and 37 Shape Memory Staples
- Applicant
- Core Essence Orthopaedics, LLC
Yardley, PA, US - Received
- May 29, 2007
- Decision date
- August 15, 2007
- 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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| 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 |
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| K090128 | Tac-Tite (TM)GAT · Special | 03/19/2009SE |
| K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5GAQ · Abbreviated | 12/24/2008SE |
| K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502XMBI · Traditional | 08/10/2007SE |
Questions and answers
When was Reverto 55 and 37 Shape Memory Staples cleared by the FDA?
Reverto 55 and 37 Shape Memory Staples (K071477) received a 510(k) decision of Substantially Equivalent on August 15, 2007, 78 days after the submission was received.
What is the product code of K071477?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.