Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008773560

FEI Number

3008773560

Entity Name

BIOGENNIX, LLC

City/State/Country

Irvine, CA, US

Establishment Address

18009 Sky Park Cir Ste K, Irvine, CA 92614, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biogennix, LLC (Owner Number: 10030571)

Owner / Operator Contact Address

18007 Sky Park Circle, Suite D, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142828

PMA Number

N/A

All Registered Proprietary Names

Articulating Awl Guide Slap Hammer Instrument Tray with Caddy Cover Plate Driver with Torque Handle Angulating Screwdriver with Handle Straight Screwdriver with Handle Direct Cell Agilon Agilon Strip Trials with Trial Inserter Rasps with Rasp Inserter Bullet Distractors with Bullet Distractor Inserter Tamp Spacer Remover Agilon Moldable Simple Inserter Morpheus PURcore MAC-Fuse PRY-Fuse

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-12-21
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-12-21
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-12-21
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2020-09-24
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-09-24
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2019-08-13
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-04-10
HWT	Template	Orthopedic	Class 1	888.4800	2017-12-21
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2017-12-21
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2017-12-21
HXG	Tamp	Orthopedic	Class 1	888.4540	2017-12-21
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-12-21
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-02-20
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2017-12-21
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2016-02-15

Official Correspondent

Edwin Shors

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biogennix, 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008773560. Last updated year: 2026. Please use registration number 3008773560 when referencing this establishment in official correspondence.