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FDA 510(k)

Fusion Silastic System

K-Number: K190136 · 2019-10-21

ApplicantFusion Orthopedics, LLC
Decision Date2019-10-21
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fusion Silastic System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2019-10-21 under 510(k) number K190136. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion Silastic System?

Fusion Silastic System is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K190136.

When did Fusion Silastic System receive FDA 510(k) clearance?

Fusion Silastic System received FDA 510(k) clearance on 2019-10-21, under 510(k) number K190136.

Who is the listed applicant for Fusion Silastic System?

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

What is the FDA product code for Fusion Silastic System?

The FDA product code for Fusion Silastic System is KWH.

Other records listing Fusion Orthopedics, LLC as applicant

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Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC

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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