Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019403037

FEI Number

3019403037

Entity Name

HERAEUS MEDICAL LLC - BIORESOBABLES

City/State/Country

Yardley, PA, US

Establishment Address

770 Township Line Rd Ste 300, Yardley, PA 19067, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Heraeus Medical LLC - Bioresobables (Owner Number: 10093722)

Owner / Operator Contact Address

770 Township Line Rd., Suite 300, Yardley, PA 19067, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250141

PMA Number

N/A

All Registered Proprietary Names

Synthecure

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-06-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Heraeus Medical LLC - Bioresobables

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019403037. Last updated year: 2026. Please use registration number 3019403037 when referencing this establishment in official correspondence.