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FDA 510(k)

CranioXpand

K-Number: K230211 · 2023-11-21

ApplicantKLS-Martin L.P.
Decision Date2023-11-21
Product CodePBJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CranioXpand is a medical device manufactured by KLS-Martin L.P.. It received FDA 510(k) clearance on 2023-11-21 under approval number K230211. 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 CranioXpand?

CranioXpand is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by KLS-Martin L.P.. The 510(k) number is K230211.

When was CranioXpand approved by the FDA?

CranioXpand received FDA 510(k) clearance on 2023-11-21, under approval number K230211.

What company makes CranioXpand?

CranioXpand is manufactured by KLS-Martin L.P..

What is the FDA product code for CranioXpand?

The FDA product code for CranioXpand is PBJ.

Other Devices by KLS-Martin L.P.

K153482KLS Martin Thoracic Plating System K181241KLS Martin Individual Patient Solutions (IPS) Planning System K180962KLS Martin Individual Patient Solutions K191028KLS Martin Individual Patient Solutions K182889KLS Martin Individual Patient Solutions (IPS) Planning System K182789KLS Martin Individual Patient Solutions (IPS) Planning System

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Related Devices (Code: PBJ)

K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC 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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