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FDA 510(k)

Thunderbolt System

K-Number: K261632 · 2026-07-20

ApplicantResponsive Arthroscopy, Inc.
Decision Date2026-07-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Thunderbolt System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Arthroscopy, Inc.. It received FDA 510(k) clearance on 2026-07-20 under 510(k) number K261632. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thunderbolt System?

Thunderbolt System is a medical device that received FDA 510(k) clearance on 2026-07-20. The listed applicant is Responsive Arthroscopy, Inc.. The 510(k) number is K261632.

When did Thunderbolt System receive FDA 510(k) clearance?

Thunderbolt System received FDA 510(k) clearance on 2026-07-20, under 510(k) number K261632.

Who is the listed applicant for Thunderbolt System?

The FDA 510(k) record lists Responsive Arthroscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thunderbolt System?

The FDA product code for Thunderbolt System is MBI.

Other records listing Responsive Arthroscopy, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261968Q-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)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.K261363Y-Knotless™ Flex AnchorsCONMED CorporationK253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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