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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 the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) 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. The listed applicant is KLS-Martin L.P.. The 510(k) number is K230211.

When did CranioXpand receive FDA 510(k) clearance?

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

Who is the listed applicant for CranioXpand?

The FDA 510(k) record lists KLS-Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CranioXpand?

The FDA product code for CranioXpand is PBJ.

Other records listing KLS-Martin L.P. as applicant

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.

K254162KLS Martin Ixos SystemK253660KLS Martin Pure Pectus SystemK250988KLS Martin Pure Pectus SystemK250865KLS Martin IPS Forearm SystemK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEK250620KLS Martin Ixos System

View all 32 devices →

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.

K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK163315Internal 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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