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FDA 510(k)

VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT

K-Number: K120667 · 2012-04-04

ApplicantSmith & Nephew, Inc.
Decision Date2012-04-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2012-04-04 under 510(k) number K120667. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT?

VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT is a medical device that received FDA 510(k) clearance on 2012-04-04. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K120667.

When did VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT receive FDA 510(k) clearance?

VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT received FDA 510(k) clearance on 2012-04-04, under 510(k) number K120667.

Who is the listed applicant for VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT?

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

What is the FDA product code for VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT?

The FDA product code for VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT is HRS.

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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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