Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011196443

FEI Number

3011196443

Entity Name

VISIONARE LLC

City/State/Country

Fort Myers, FL, US

Establishment Address

12220 ITEC Haul Dr, Units 215/216, Fort Myers, FL 33913, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Visionare LLC (Owner Number: 10047752)

Owner / Operator Contact Address

12220 ITEC Haul Dr, Units 215/216, Fort Myers, FL 33913, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Visionare Visionare Visionare Visionare Visionare VISIONARE Visionare Visionare Visionare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-12-03
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-12-03
HWT	Template	Orthopedic	Class 1	888.4800	2018-12-03
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2018-12-03
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2018-12-03
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2019-01-08
JEY	Plate, Bone	Dental	Class 2	872.4760	2019-01-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2018-12-03
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2018-12-03
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-12-03

Official Correspondent

Pedro Oliveira de Carvalho

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Visionare LLC

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
K172572	Stryker	Stryker Upper-Face AXS screws and Mid-Face AXS screws	2017-10-31
K121589	Biomet Microfixation	BIOMET MICROFIXATION FACIAL PLATING SYSTEM	2012-09-21
K984230	Osteogenics Biomedical, Inc.	OSTEO-MESH TM-300	1999-02-04
K021618	Osteomed Corp.	OSA RIGID INTERNAL FIXATION SYSTEM	2002-08-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2007	Bioplate Inc	2	Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

Similar Registrations

Registration Number	Establishment Name	Location
9610622	STRYKER TRAUMA GMBH	SCHOENKIRCHEN Schleswig-Holstein, DE
3036795921	KLS MARTIN SE & CO. KG	Fridingen Baden-Wurttemberg, DE
1020279	SMITH & NEPHEW, INC.	MEMPHIS, TN, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
3012755988	Ortho Solutions Sdn Bhd	Prai, Penang Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011196443. Last updated year: 2026. Please use registration number 3011196443 when referencing this establishment in official correspondence.