Shadow Knotless All-Suture Anchors— 510(k) K233258
Substantially EquivalentResponsive Arthroscopy, LLC
FDA 510(k) clearance K233258 for Shadow Knotless All-Suture Anchors, Substantially Equivalent on 2023-10-23. Applicant: Responsive Arthroscopy, LLC. Device class: 2.
Clearance details
- Applicant
- Responsive Arthroscopy, LLC
- 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
- Minneapolis, MN, US
Recent devices under product code MBI
view allMore clearances from Responsive Arthroscopy, LLC
view all- K253010 — Mini Superhawk Suture Anchor System
- K230094 — Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
- K222763 — Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
- K203121 — Responsive Arthroscopy Thunderbolt System
- K202569 — Responsive Arthroscopy Interference Screw System
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.