Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2081135

FEI Number

2081135

Entity Name

PRO-DEX, INC.

City/State/Country

Irvine, CA, US

Establishment Address

2361 McGaw Avenue, Irvine, CA 92614, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

PRO-DEX, INC. (Owner Number: 2081135)

Owner / Operator Contact Address

2361 McGaw Avenue, --, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro-Dex Surgical Driver (PDSD-5000-X) PDCMF Driver (PDCMF-1000-X) Atlas Pro Driver Hex Collet (APD-CA-001-1) Atlas Pro Driver (APD-1000-1) Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1) Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBP-040-X) Pro-Dex Surgical Driver, Single Pouch Battery Pack (PDBP-001-X; PDBP-010-X; PDBD-040-X) Pro-Dex Surgical Driver (PDSD-5000-X) Atlas Pro Driver Battery Single Use Battery Case (APD-BP-010S-1) Atlas Pro Driver Hex Collet (APD-CA-001-1) Atlas Pro Driver (APD-1000-1) PDCMF Power Driver (PDCMF-1000-X) Dynatip P/N 3293 Tip, Cover / Protector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXL	Screwdriver, Skullplate	Neurology	Class 1	882.4900	2013-03-28
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2015-03-07
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-07-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-03-28
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	1992-10-23
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2021-12-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRO-DEX, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3024788684	Pro-Dex Inc	Tustin, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
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.

Similar Registrations

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9610905	KLS Martin SE & Co. KG	Muhlheim/Donau Baden-Wurttemberg, DE
9613926	Gesco Healthcare Private Limited	CHENNAI, Tamil Nadu, IN
3024788684	Pro-Dex Inc	Tustin, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2081135. Last updated year: 2026. Please use registration number 2081135 when referencing this establishment in official correspondence.