Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010131978

FEI Number

3010131978

Entity Name

ORBIS MEDICAL, LLC

City/State/Country

Palmetto Bay, FL, US

Establishment Address

17125 SW 81st Ct, Palmetto Bay, FL 33157, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Orbis Medical, LLC (Owner Number: 10043155)

Owner / Operator Contact Address

17125 SW 81 Court, Palmetto Bay, FL 33157, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drill Bit External Fixation System Surgical Tray General Manual Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2014-05-09
NDK	System, External Fixator (With Metallic Invasive Components)	Orthopedic	Class 2	888.3040	2013-01-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-05-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2014-05-09

Official Correspondent

Christopher Endara

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orbis Medical, LLC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3023265483	PHEN'X TECHNOLOGIES	Chassieu Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010131978. Last updated year: 2026. Please use registration number 3010131978 when referencing this establishment in official correspondence.