FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Infinity-Lock Button System
K Number: K180243
·
Decision Apr 3, 2018
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
9
Review Days
64
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Basic Information
- Device Name
- Infinity-Lock Button System
- K Number
- K180243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xiros, Ltd.
- Date Received
- January 29, 2018
- Decision Date
- April 3, 2018
- Product Code
- HTN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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Other Clearances by Xiros, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230671 | Pitch PaSoft Tissue Reinforcement Device | May 31, 2023 | Substantially Equivalent |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Dec 27, 2022 | Substantially Equivalent |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Aug 26, 2022 | Substantially Equivalent |
| K220906 | SECURE-LOCK | Jul 22, 2022 | Substantially Equivalent |
| K211563 | Pitch-Patchs | Aug 13, 2021 | Substantially Equivalent |
| K191053 | Xtreme-Loop | Jul 17, 2019 | Substantially Equivalent |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | Jun 30, 2017 | Substantially Equivalent |
| K151601 | SECURE-LOOP | Sep 9, 2015 | Substantially Equivalent |