AGNOVOS HEALTHCARE USA, LLC

FDA Device Registration & Listing · Rockville, MD, US · Registration 3011662387

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011662387
FEI Number
3011662387
Entity Name
AGNOVOS HEALTHCARE USA, LLC
City/State/Country
Rockville, MD, US
Establishment Address
7301 CALHOUN PL STE 100, Rockville, MD 20855, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
AgNovos Healthcare (Owner Number: 10055038)
Owner / Operator Contact Address
7301 Calhoun Pl Ste 100, Rockville, MD 20855, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181342
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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 2018-10-04
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-10-04

Official Correspondent

Daniel Plonski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AgNovos Healthcare
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 3011662387. Last updated year: 2026. Please use registration number 3011662387 when referencing this establishment in official correspondence.
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