Palacos R

FDA 510(k) K030902 · Heraeus Kulzer GmbH & Co. KG

Substantially Equivalent

510(k) numberK030902

Submission

Device name
Palacos R
Applicant
Heraeus Kulzer GmbH & Co. KG
Hanau, DE
Received
March 24, 2003
Decision date
September 23, 2003
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LOD – Bone Cement
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3027
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Palacos R cleared by the FDA?

Palacos R (K030902) received a 510(k) decision of Substantially Equivalent on September 23, 2003, 183 days after the submission was received.

What is the product code of K030902?

The FDA product code is LOD – Bone Cement, a Class II (moderate risk) device regulated under 21 CFR 888.3027.