Toggleloc and Juggerloc Implants/Instruments/Kits
FDA 510(k) K141263 · Biomet Manufacturing Corp
510(k) numberK141263
Submission
- Device name
- Toggleloc and Juggerloc Implants/Instruments/Kits
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- May 15, 2014
- Decision date
- November 19, 2014
- 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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| 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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Questions and answers
When was Toggleloc and Juggerloc Implants/Instruments/Kits cleared by the FDA?
Toggleloc and Juggerloc Implants/Instruments/Kits (K141263) received a 510(k) decision of Substantially Equivalent on November 19, 2014, 188 days after the submission was received.
What is the product code of K141263?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.