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Osteomed Smartflex Cranial Spring Distraction System

by Osteomed LP

510(k) K123885

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123885 Date3 Jun 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Osteomed Smartflex Cranial Spring Distractor
510(k) Number
FDA Product Code
PBJ
Device Class
Class II
Regulation
21 CFR Part 882.5330
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Osteomed Smartflex Cranial Spring Distraction System is a cranial distraction system used in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies. It provides temporary stabilization and gradual lengthening of the cranial bones through osteotomies and gradual bone distraction.

The device is supplied as a single-use system, manufactured with medical grade stainless steel, and is intended to be removed after treatment. It is available with pre-formed cranial springs and beveled foot plates designed to fit securely under the skull bone, and has been authorized with an FDA 510K clearance.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Smartflex Cranial Spring Distraction System used for?

    The Smartflex Cranial Spring Distraction System is used in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies, providing temporary stabilization and gradual lengthening of the cranial bones.

  • Is the Smartflex Cranial Spring Distraction System reusable?

    No, the Smartflex Cranial Spring Distraction System is supplied as a single-use system and is intended to be removed after treatment.

  • What materials are used to manufacture the Smartflex Cranial Spring Distraction System?

    The Smartflex Cranial Spring Distraction System is manufactured with medical grade stainless steel.