WHK BIOSYSTEMS, LLC

FDA Device Registration & Listing · Clearwater, FL, US · Registration 3010473074

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
3010473074
FEI Number
3010473074
Entity Name
WHK BIOSYSTEMS, LLC
City/State/Country
Clearwater, FL, US
Establishment Address
11345 53rd St N, Clearwater, FL 33760, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
WHK BioSystems, LLC / Bergman (Owner Number: 10045062)
Owner / Operator Contact Address
11345 53rd Street North, Clearwater, FL 33760, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hydro Putty Hydro Fiber

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 2025-02-12
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2025-02-12

Official Correspondent

Victoria Bergman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

WHK BioSystems, LLC / Bergman
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 3010473074. Last updated year: 2026. Please use registration number 3010473074 when referencing this establishment in official correspondence.
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