Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039103971

FEI Number

3039103971

Entity Name

CGBIO USA, INC.

City/State/Country

Irvine, CA, US

Establishment Address

41 Corporate Park Ste 200, Irvine, CA 92606, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CGBIO USA, Inc. (Owner Number: 10094982)

Owner / Operator Contact Address

41 Corporate park, suite 200, Irvine, CA 92606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

[Target] TFR0001 Freer [Target] TML0001 Mallet [Target] TCH0001L Straight Chisel 5mm [Target] TCH0004L Pedicle Chisel 4mm [Target] TCH0002L Hockey Chisel Left 5mm [Target] TCH0003L Hockey Chisel Right 5mm [Target] TST0001-2 Obturator [Target] TSD0001-3 Serial Dilator [Target] TSD0001-1 Serial Dilator [Target] TST0001 Sheath [Target] TST0001-1 Obturator [Target] TDI0001 Dilator [Target] TSD0001-2 Serial Dilator [Target] TSD0001 Serial Dilator Set EASYMADE-TI [Target] TCU0006 Boomerang Curette 3mm [Target] TCU0005 Reverse Curette 3mm [Target] TCU0003 Bone Curette 5mm Maximus [Target] TCU0004 Bone Curette 6mm Wang [Target] TCU0002 Bone Curette 3mm Bishop [Target] TFP0001 Foraminal Punch 2mm [Target] TRP0002 Rotational Punch Head 3mm [Target] TFP0002 Foraminal Punch 3mm [Target] TRP0001 Rotational Punch Head 2mm [Target] TVP0001 Viewing portal Retractor straight [Target] TUV0050 UV Retractor 50mm [Target] TRR0001 Root Retractor [Target] TUV0060 UV Retractor 60mm [Target] TUV0040 UV Retractor 40mm [Target] TVP0002 Viewing portal Retractor curved

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-01-27
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2026-01-27
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2026-01-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2026-01-27
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2026-05-13
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-27
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-01-27
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2026-01-27

Official Correspondent

Jumi Han

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CGBIO USA, Inc.

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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9611102	RICHARD WOLF GMBH	KNITTLINGEN Baden-Wurttemberg, DE
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039103971. Last updated year: 2026. Please use registration number 3039103971 when referencing this establishment in official correspondence.