Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OSTEOPAL® V

K-Number: K241674 · 2024-12-05

ApplicantHeraeus Medical GmbH
Decision Date2024-12-05
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOPAL® V is a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2024-12-05 under approval number K241674. 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 OSTEOPAL® V?

OSTEOPAL® V is a medical device that received FDA 510(k) clearance on 2024-12-05. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K241674.

When was OSTEOPAL® V approved by the FDA?

OSTEOPAL® V received FDA 510(k) clearance on 2024-12-05, under approval number K241674.

What company makes OSTEOPAL® V?

OSTEOPAL® V is manufactured by Heraeus Medical GmbH.

What is the FDA product code for OSTEOPAL® V?

The FDA product code for OSTEOPAL® V is LOD.

Other Devices by Heraeus Medical GmbH

K153737OSTEOPAL plus K182260PALACOS MV K191016COPAL exchange G Hip and Knee Spacers K190766PALACOS fast R+G K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

View all 11 devices →

Related Devices (Code: LOD)

K153737OSTEOPAL plusHeraeus Medical GmbH K172408Biomet Bone Cement RBiomet, Inc. K170802TRAUMACEM™ V+ Injectable Bone CementSynthes (USA) Products, LLC K171540Refobacin Bone Cement RBiomet, Inc. K182260PALACOS MVHeraeus Medical GmbH K173494OrthoSteady G Bone CementG21, S.R.L.

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.

↑