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FDA 510(k)

Taps for Resorbable Screws

K-Number: K153587 · 2017-01-18

ApplicantSynthes (USA) Products, LLC
Decision Date2017-01-18
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Taps for Resorbable Screws is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2017-01-18 under 510(k) 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. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K153587.

When did Taps for Resorbable Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for Taps for Resorbable Screws?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Synthes (USA) Products, LLC as applicant

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Related Devices (Code: HBG)

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.

K252696LEGACYPhasor Health, LLCK162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.

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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