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FDA 510(k)

OSTEOMED CRANIAL DISTRACTION SYSTEM

K-Number: K121304 · 2012-08-22

ApplicantOsteomed
Decision Date2012-08-22
Product CodePBJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED CRANIAL DISTRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed. It received FDA 510(k) clearance on 2012-08-22 under 510(k) number K121304. 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 OSTEOMED CRANIAL DISTRACTION SYSTEM?

OSTEOMED CRANIAL DISTRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-22. The listed applicant is Osteomed. The 510(k) number is K121304.

When did OSTEOMED CRANIAL DISTRACTION SYSTEM receive FDA 510(k) clearance?

OSTEOMED CRANIAL DISTRACTION SYSTEM received FDA 510(k) clearance on 2012-08-22, under 510(k) number K121304.

Who is the listed applicant for OSTEOMED CRANIAL DISTRACTION SYSTEM?

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

What is the FDA product code for OSTEOMED CRANIAL DISTRACTION SYSTEM?

The FDA product code for OSTEOMED CRANIAL DISTRACTION SYSTEM is PBJ.

Related Clinical Trials

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Other records listing Osteomed 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.

K203479ExtremiLOCK Lateral Ankle Fusion PlatesK162542OsteoMed PINNACLE DriverK162544OsteoMed PINNACLE DriverK161041OsteoMed ExtremiLOCK Wrist Plating SystemK131851OSTEOMED NEURO RONGEURK1334371ST MTP PLATE

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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.K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK163315Internal Distraction - SterileKLS Martin L.P.K123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOROsteomed LP

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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