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VERTECEM

by Teknimed, S.A.

510(k) K090435

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK090435 Date21 Dec 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NDN
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

VERTECEM is a bone cement used for the fixation of pathological fractures of the vertebral body through vertebroplasty or kyphoplasty procedures. It is designed to address painful vertebral compression fractures that may result from osteoporosis or benign lesions.

The device is supplied as a sterile product and is intended for single-use. VERTECEM has FDA 510(k) clearance with the product code NDN and is classified under the orthopedic specialty. It is manufactured by Teknimed, S.A. and has the model number K090435.

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