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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2017-09-28 under 510(k) 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. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K170802.

When did TRAUMACEM™ V+ Injectable Bone Cement receive FDA 510(k) clearance?

TRAUMACEM™ V+ Injectable Bone Cement received FDA 510(k) clearance on 2017-09-28, under 510(k) number K170802.

Who is the listed applicant for TRAUMACEM™ V+ Injectable Bone Cement?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: LOD)

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.

K254107Refobacin Bone Cement R (110034355)Biomet FranceK250760SPECTRUM GV Bone CementOsteoremedies, LLCK241674OSTEOPAL® VHeraeus Medical GmbHK231556SPECTRUM® GV Bone CementOsteoremedies, LLCK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda

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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