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FDA 510(k)

SUTURE ARROW

K-Number: K041128 · 2004-07-29

ApplicantLinvatec Corp.
Decision Date2004-07-29
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTURE ARROW is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2004-07-29 under 510(k) number K041128. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE ARROW?

SUTURE ARROW is a medical device that received FDA 510(k) clearance on 2004-07-29. The listed applicant is Linvatec Corp.. The 510(k) number is K041128.

When did SUTURE ARROW receive FDA 510(k) clearance?

SUTURE ARROW received FDA 510(k) clearance on 2004-07-29, under 510(k) number K041128.

Who is the listed applicant for SUTURE ARROW?

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

What is the FDA product code for SUTURE ARROW?

The FDA product code for SUTURE ARROW is MAI.

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Other records listing Linvatec Corp. as applicant

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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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