TRAUMACEM V+ Injectable Bone Cement
K-Number: K170802 · 2017-09-28
ApplicantSynthes (USA) Products, LLC
Decision Date2017-09-28
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TRAUMACEM V+ Injectable Bone Cement is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2017-09-28 under approval number K170802. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRAUMACEM V+ Injectable Bone Cement?
TRAUMACEM V+ Injectable Bone Cement is a medical device that received FDA 510(k) clearance on 2017-09-28. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K170802.
When was TRAUMACEM V+ Injectable Bone Cement approved by the FDA?
TRAUMACEM V+ Injectable Bone Cement received FDA 510(k) clearance on 2017-09-28, under approval number K170802.
What company makes TRAUMACEM V+ Injectable Bone Cement?
TRAUMACEM V+ Injectable Bone Cement is manufactured by Synthes (USA) Products, LLC.
What is the FDA product code for TRAUMACEM V+ Injectable Bone Cement?
The FDA product code for TRAUMACEM V+ Injectable Bone Cement is LOD.
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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.