Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031637

FEI Number

3004474407

Entity Name

FZIOMED, INC.

City/State/Country

San Luis Obispo, CA, US

Establishment Address

231 BONETTI DR, San Luis Obispo, CA 93401, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

FZIOMED, INC. (Owner Number: 9034681)

Owner / Operator Contact Address

231 BONETTI DR., --, San Luis Obispo, CA 93401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240038

PMA Number

N/A

All Registered Proprietary Names

DYNAVISC Oxiplex/AP Oxiplex/IU Intercoat AP Intercoat IU Oxiplex Oxiplex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZJ	Inhibitor, Postoperative Fibrosis (Adhesion Barrier)	Unknown	Class N	N/A	2012-03-12
MCN	Barrier, Absorbable, Adhesion	Unknown	Class 3	N/A	2009-02-17
QVL	Absorbable Gel For Intraoperative Use In Spine Surgery	Orthopedic	Class 2	888.3047	2026-06-01
QVL	Absorbable Gel For Intraoperative Use In Spine Surgery	Orthopedic	Class 2	888.3047	2025-08-14

Official Correspondent

Lisa Gawehn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FZIOMED, INC.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031637. Last updated year: 2026. Please use registration number 2031637 when referencing this establishment in official correspondence.