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FDA 510(k)

Craniomaxillofacial Distraction System (CMFD)

K-Number: K170818 · 2017-12-07

ApplicantSynthes USA Products, LLC
Decision Date2017-12-07
Product CodePBJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Craniomaxillofacial Distraction System (CMFD) 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 2017-12-07 under 510(k) number K170818. The device is classified under product code PBJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Craniomaxillofacial Distraction System (CMFD)?

Craniomaxillofacial Distraction System (CMFD) is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Synthes USA Products, LLC. The 510(k) number is K170818.

When did Craniomaxillofacial Distraction System (CMFD) receive FDA 510(k) clearance?

Craniomaxillofacial Distraction System (CMFD) received FDA 510(k) clearance on 2017-12-07, under 510(k) number K170818.

Who is the listed applicant for Craniomaxillofacial Distraction System (CMFD)?

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 Craniomaxillofacial Distraction System (CMFD)?

The FDA product code for Craniomaxillofacial Distraction System (CMFD) is PBJ.

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Related Devices (Code: PBJ)

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.

K230211CranioXpandKLS-Martin L.P.K163315Internal Distraction - SterileKLS Martin L.P.

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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