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FDA 510(k)

HARPOON SUTURE ANCHORS

K-Number: K973775 · 1998-04-16

ApplicantBiomet, Inc.
Decision Date1998-04-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HARPOON SUTURE ANCHORS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1998-04-16 under 510(k) number K973775. 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 HARPOON SUTURE ANCHORS?

HARPOON SUTURE ANCHORS is a medical device that received FDA 510(k) clearance on 1998-04-16. The listed applicant is Biomet, Inc.. The 510(k) number is K973775.

When did HARPOON SUTURE ANCHORS receive FDA 510(k) clearance?

HARPOON SUTURE ANCHORS received FDA 510(k) clearance on 1998-04-16, under 510(k) number K973775.

Who is the listed applicant for HARPOON SUTURE ANCHORS?

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

What is the FDA product code for HARPOON SUTURE ANCHORS?

The FDA product code for HARPOON SUTURE ANCHORS is MBI.

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Related Devices (Code: MBI)

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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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