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FDA 510(k)

SYNDE-LOCK SYNDESMOSIS REPAIR KIT

K-Number: K111971 · 2012-01-23

ApplicantTarsus Medical, Inc.
Decision Date2012-01-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNDE-LOCK SYNDESMOSIS REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Tarsus Medical, Inc.. It received FDA 510(k) clearance on 2012-01-23 under 510(k) number K111971. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNDE-LOCK SYNDESMOSIS REPAIR KIT?

SYNDE-LOCK SYNDESMOSIS REPAIR KIT is a medical device that received FDA 510(k) clearance on 2012-01-23. The listed applicant is Tarsus Medical, Inc.. The 510(k) number is K111971.

When did SYNDE-LOCK SYNDESMOSIS REPAIR KIT receive FDA 510(k) clearance?

SYNDE-LOCK SYNDESMOSIS REPAIR KIT received FDA 510(k) clearance on 2012-01-23, under 510(k) number K111971.

Who is the listed applicant for SYNDE-LOCK SYNDESMOSIS REPAIR KIT?

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

What is the FDA product code for SYNDE-LOCK SYNDESMOSIS REPAIR KIT?

The FDA product code for SYNDE-LOCK SYNDESMOSIS REPAIR KIT is HWC. This falls under the Cardiovascular category.

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Other records listing Tarsus Medical, 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.

K110800META-LOCK SUTURE ANCHOR SYSTEM

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Official Source

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

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