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FDA 510(k)

SUB-TALAR LOK, MODEL 7-11 MM

K-Number: K080280 · 2008-03-14

ApplicantInstratek, Inc.
Decision Date2008-03-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUB-TALAR LOK, MODEL 7-11 MM is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 2008-03-14 under 510(k) number K080280. 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 SUB-TALAR LOK, MODEL 7-11 MM?

SUB-TALAR LOK, MODEL 7-11 MM is a medical device that received FDA 510(k) clearance on 2008-03-14. The listed applicant is Instratek, Inc.. The 510(k) number is K080280.

When did SUB-TALAR LOK, MODEL 7-11 MM receive FDA 510(k) clearance?

SUB-TALAR LOK, MODEL 7-11 MM received FDA 510(k) clearance on 2008-03-14, under 510(k) number K080280.

Who is the listed applicant for SUB-TALAR LOK, MODEL 7-11 MM?

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

What is the FDA product code for SUB-TALAR LOK, MODEL 7-11 MM?

The FDA product code for SUB-TALAR LOK, MODEL 7-11 MM is HWC. This falls under the Cardiovascular category.

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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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