Infinity-Lock Button System
FDA 510(k) K180243 · Xiros, Ltd.
510(k) numberK180243
Submission
- Device name
- Infinity-Lock Button System
- Applicant
- Xiros, Ltd.
Leeds, GB - Received
- January 29, 2018
- Decision date
- April 3, 2018
- 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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| K191053 | Xtreme-LoopMBI · Traditional | 07/17/2019SE |
| K171680 | Infinity-Lock 3, Infinity-Lock 5GAT · Special | 06/30/2017SE |
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Questions and answers
When was Infinity-Lock Button System cleared by the FDA?
Infinity-Lock Button System (K180243) received a 510(k) decision of Substantially Equivalent on April 3, 2018, 64 days after the submission was received.
What is the product code of K180243?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.