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FDA 510(k)

ARTHREX SCAPHOLUNATE ANCHOR

K-Number: K111661 · 2011-08-19

ApplicantArthrex, Inc.
Decision Date2011-08-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX SCAPHOLUNATE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2011-08-19 under 510(k) number K111661. 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 ARTHREX SCAPHOLUNATE ANCHOR?

ARTHREX SCAPHOLUNATE ANCHOR is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Arthrex, Inc.. The 510(k) number is K111661.

When did ARTHREX SCAPHOLUNATE ANCHOR receive FDA 510(k) clearance?

ARTHREX SCAPHOLUNATE ANCHOR received FDA 510(k) clearance on 2011-08-19, under 510(k) number K111661.

Who is the listed applicant for ARTHREX SCAPHOLUNATE ANCHOR?

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

What is the FDA product code for ARTHREX SCAPHOLUNATE ANCHOR?

The FDA product code for ARTHREX SCAPHOLUNATE ANCHOR is MBI.

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Other records listing Arthrex, 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.

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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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