FDA 510(k)

Taps for Resorbable Screws

K-Number: K153587 · 2017-01-18

Decision Date2017-01-18

Product CodeHBG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Taps for Resorbable Screws is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2017-01-18 under approval number K153587. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Taps for Resorbable Screws?

Taps for Resorbable Screws is a medical device that received FDA 510(k) clearance on 2017-01-18. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K153587.

When was Taps for Resorbable Screws approved by the FDA?

Taps for Resorbable Screws received FDA 510(k) clearance on 2017-01-18, under approval number K153587.

What company makes Taps for Resorbable Screws?

Taps for Resorbable Screws is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for Taps for Resorbable Screws?

The FDA product code for Taps for Resorbable Screws is HBG.

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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.