Thunderbolt System— 510(k) K261632
Substantially EquivalentResponsive Arthroscopy, Inc.
FDA 510(k) clearance K261632 for Thunderbolt System, Substantially Equivalent on 2026-07-20. Applicant: Responsive Arthroscopy, Inc.. Device class: 2.
Clearance details
- Applicant
- Responsive Arthroscopy, 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
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code MBI
view all- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)
- K260018 — Arthrex FiberButton
- K253130 — Dione PEEK Screw System
- K261363 — Y-Knotless Flex Anchors
- K253027 — Anchor with Fiber Wire and Disposable Inserter
More clearances from Responsive Arthroscopy, Inc.
view allAdverse 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.