PALACOS MV Pro

Bone Cement

Heraeus Medical GmbH

The following data is part of a premarket notification filed by Heraeus Medical Gmbh with the FDA for Palacos Mv Pro.

Pre-market Notification Details

Device IDK213812
510k NumberK213812
Device Name:PALACOS MV Pro
ClassificationBone Cement
Applicant Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim,  DE 61273
ContactLjuba Jaeckel
CorrespondentLjuba Jaeckel
Heraeus Medical GmbH Philipp-Reis-Str. 8/13 Wehrheim,  DE 61273
Product CodeLOD  
Subsequent Product CodeJDZ
Subsequent Product CodeKIH
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-07
Decision Date2022-02-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260102135376 K213812 000
04260102135338 K213812 000

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