Arthrotek Maxfire Meniscal Repair Device
FDA 510(k) K061776 · Arthrotek, Inc.
510(k) numberK061776
Submission
- Device name
- Arthrotek Maxfire Meniscal Repair Device
- Applicant
- Arthrotek, Inc.
Warsaw, IN, US - Received
- June 23, 2006
- Decision date
- September 25, 2006
- 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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| 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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| K060693 | Microstrike and Allthread PEEK Suture AnchorHWC · Traditional | 06/06/2006SE |
| K053461 | Ezloc Femoral Fixation DeviceMBI · Traditional | 02/03/2006SE |
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| K042460 | Ti - Screw Anchor SPMBI · Traditional | 10/29/2004SE |
| K041274 | Resorbable Interference ScrewHWC · Traditional | 07/28/2004SE |
| K041261 | Femoral HookMBI · Special | 06/07/2004SE |
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Questions and answers
When was Arthrotek Maxfire Meniscal Repair Device cleared by the FDA?
Arthrotek Maxfire Meniscal Repair Device (K061776) received a 510(k) decision of Substantially Equivalent on September 25, 2006, 94 days after the submission was received.
What is the product code of K061776?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.