ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor— 510(k) K173074
Substantially EquivalentStryker
FDA 510(k) clearance K173074 for ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor, Substantially Equivalent on 2018-04-04. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- 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
- Special
- Location
- Greenwood Village, CO, 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.