ULTRABUTTON QUAD Adjustable Fixation Device +4 more— 510(k) K222971
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K222971 for ULTRABUTTON QUAD Adjustable Fixation Device +4 more, Substantially Equivalent on 2023-02-17. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Device name as filed
- ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
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Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.