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FDA 510(k)

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

K-Number: K123885 · 2013-06-03

ApplicantOsteomed LP
Decision Date2013-06-03
Product CodePBJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed LP. It received FDA 510(k) clearance on 2013-06-03 under 510(k) number K123885. 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 SMARTFLEX CRANIAL SPRING DISTRACTOR?

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR is a medical device that received FDA 510(k) clearance on 2013-06-03. The listed applicant is Osteomed LP. The 510(k) number is K123885.

When did OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR receive FDA 510(k) clearance?

OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR received FDA 510(k) clearance on 2013-06-03, under 510(k) number K123885.

Who is the listed applicant for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR?

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

What is the FDA product code for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR?

The FDA product code for OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR 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.K170818Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLCK163315Internal Distraction - SterileKLS Martin L.P.K121304OSTEOMED CRANIAL DISTRACTION SYSTEMOsteomed

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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