Biomet Sports Medicine Sternal Closure System
FDA 510(k) K110039 · Biomet Sports Medicine
510(k) numberK110039
Submission
- Device name
- Biomet Sports Medicine Sternal Closure System
- Applicant
- Biomet Sports Medicine
Warsaw, IN, US - Received
- January 6, 2011
- Decision date
- May 3, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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| K233949 | ACCORD Cable SystemJDQ · Traditional | Smith & Nephew, Inc. | 03/13/2024SE |
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| K221795 | STERN FIX Sternal Stabilization SystemJDQ · Traditional | Neos Surgery S.L | 10/19/2022SE |
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| K123485 | Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…MBI · Traditional | 03/18/2013SE |
| K110879 | Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorMBI · Traditional | 08/19/2011SE |
| K111564 | Maxfire Marxmen Meniscal Repair DeviceMBI · Special | 06/16/2011SE |
| K103145 | Hammerloc TM Tibial Fixation DeviceMBI · Traditional | 02/09/2011SE |
| K101063 | Sleeve with Ziploop Fixation DevicesMBI · Traditional | 06/23/2010SE |
| 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 Biomet Sports Medicine Sternal Closure System cleared by the FDA?
Biomet Sports Medicine Sternal Closure System (K110039) received a 510(k) decision of Substantially Equivalent on May 3, 2011, 117 days after the submission was received.
What is the product code of K110039?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.