PALACOS R Pro, PALACOS R+G Pro, PALACOS MV+G 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 R Pro, Palacos R+g Pro, Palacos Mv+g Pro.

Pre-market Notification Details

Device IDK210607
510k NumberK210607
Device Name:PALACOS R Pro, PALACOS R+G Pro, PALACOS MV+G Pro
ClassificationBone Cement
Applicant Heraeus Medical GmbH Phillipp-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
Subsequent Product CodeMBB
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-03-01
Decision Date2021-07-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04260102136281 K210607 000
04260102136250 K210607 000
04260102136229 K210607 000
04260102136199 K210607 000
04260102136168 K210607 000
04260102136120 K210607 000

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