Juggerknot Mini Soft Anchor
FDA 510(k) K140908 · Biomet Sports Medicine
510(k) numberK140908
Submission
- Device name
- Juggerknot Mini Soft Anchor
- Applicant
- Biomet Sports Medicine
Warsaw, IN, US - Received
- April 9, 2014
- Decision date
- October 2, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
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| K111564 | Maxfire Marxmen Meniscal Repair DeviceMBI · Special | 06/16/2011SE |
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| K083070 | Toggleloc SystemMBI · Traditional | 12/16/2008SE |
| K071816 | Harpoon Suture AnchorHWC · Traditional | 09/20/2007SE |
| K071704 | Sleeve and Button Soft Tissue DevicesMBI · Traditional | 09/17/2007SE |
Questions and answers
When was Juggerknot Mini Soft Anchor cleared by the FDA?
Juggerknot Mini Soft Anchor (K140908) received a 510(k) decision of Substantially Equivalent on October 2, 2014, 176 days after the submission was received.
What is the product code of K140908?
The FDA product code is DZL – Screw, Fixation, Intraosseous, a Class II (moderate risk) device regulated under 21 CFR 872.4880.