Bolo Button System
FDA 510(k) K242091 · Fusion Orthopedics
510(k) numberK242091
Submission
- Device name
- Bolo Button System
- Applicant
- Fusion Orthopedics
Mesa, AZ, US - Received
- July 17, 2024
- Decision date
- December 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K182684 | HammerTechTM Fixation SystemHWC · Traditional | 11/23/2018SE |
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Questions and answers
When was Bolo Button System cleared by the FDA?
Bolo Button System (K242091) received a 510(k) decision of Substantially Equivalent on December 23, 2024, 159 days after the submission was received.
What is the product code of K242091?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.