Medical Device Manufacturer · DE , Wehrheim

Heraeus Medical GmbH - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2014

Recent clearances: OSTEOPAL® V, COPAL® exchange G hip spacer, COPAL knee moulds

Total

Cleared

Denied

Heraeus Medical GmbH has 13 FDA 510(k) cleared orthopedic devices. Based in Wehrheim, DE.

Latest FDA clearance: Dec 2024. Active since 2014.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Alira Health as regulatory consultant.

Heraeus Medical GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Heraeus Medical GmbH

13 devices

1-13 of 13

COPAL® exchange G hip spacer

COPAL exchange G hip spacer

PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

K210607 · LOD

Orthopedic · 130d

Cleared Nov 23, 2020

PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

K202475 · LOD

Orthopedic · 87d

Cleared Nov 01, 2019

COPAL exchange G Hip and Knee Spacers

Heraeus Medical GmbH - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Heraeus Medical GmbH

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