Cohesion Bone Cement

FDA 510(k) K103816 · Teknimed Sas

Substantially Equivalent

510(k) numberK103816

Submission

Device name
Cohesion Bone Cement
Applicant
Teknimed Sas
Round Rock, TX, US
Received
December 29, 2010
Decision date
February 4, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NDN – Cement, Bone, Vertebroplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code NDN

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K251896XeliteMed SuperM-Fix Spinal Bone CementNDN · Traditional Xelite Biomed , Ltd.01/28/2026SE
K250637VCFix Spinal SystemNDN · Traditional Amber Implants05/30/2025SE
K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemNDN · Traditional Xelite Biomed , Ltd.04/11/2025SE
K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementNDN · Traditional Xelite Biomed , Ltd.09/18/2024SE
K232842Balloon Inflation SystemNDN · Traditional Ningbo Hicren Biotechnology Co., Ltd.02/29/2024SE
K240084V-STRUT® Vertebral ImplantNDN · Special Hyprevention02/09/2024SE
K231340Renova Spine Balloon CatheterNDN · Traditional Biopsybell S.R.L.10/30/2023SE
K221697Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional Slk Ortho, LLC03/03/2023SE
K223294SpineJack® Expansion KitNDN · Traditional Stryker Instruments12/20/2022SE
K220131KYPHON VuE Bone CementNDN · Traditional Tecres S.P.A.04/18/2022SE

More from Tecres S.P.A.

510(k)DeviceDecision
K242216Gentafix® (1, 3, 3MV)MBB · Traditional 12/18/2024SE
K230394Euroscrew NG; Euroscrew TCP NGMAI · Traditional 05/12/2023SE
K161114High V+NDN · Traditional 04/12/2017SE

Questions and answers

When was Cohesion Bone Cement cleared by the FDA?

Cohesion Bone Cement (K103816) received a 510(k) decision of Substantially Equivalent on February 4, 2011, 37 days after the submission was received.

What is the product code of K103816?

The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.