Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016948539

FEI Number

3008066433

Entity Name

GENESIS BIOLOGICS, INC.

City/State/Country

Irvine, CA, US

Establishment Address

17791 Mitchell North, Suite D, Irvine, CA 92614, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Genesis Biologics, Inc. (Owner Number: 10074842)

Owner / Operator Contact Address

17791 Mitchell North, Suite D, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203523

PMA Number

N/A

All Registered Proprietary Names

Genesis Push-In Suture Anchor Genesis Screw-In Anchor Genesis Dual Thread Screw-In Anchor AlternatiV+ Screw-In Anchor Awl/Tapper Awl Dual Pitch AWL/Tapper Genesis Drill Bit Genesis Dual Pitch AWL/Tapper Genesis Drill Guide Drill Bit Genesis Awl/Tapper Genesis Awl Drill Guide AlternatiV+ Max Knotless Anchor Genesis Knotless Anchor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-08-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-01-20
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-01-20

Official Correspondent

Steven Bee

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Genesis Biologics, 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
K203334	Acuitive Technologies, Inc.	The Citrefix Knotless Suture Anchor	2021-02-05
K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	2024-12-03
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28

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

Registration Number	Establishment Name	Location
1054811	Sterigenics U.S. LLC	MULBERRY, FL, US
3016851379	Arthrex Distribution Hub EMEA B.V.	Venlo Limburg, NL
3006638824	ETHICON, INC.	CIUDAD JUAREZ Chihuahua, MX
3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
3008868758	EXEL INC. DBA DHL SUPPLY CHAIN (USA)	Mooresville, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016948539. Last updated year: 2026. Please use registration number 3016948539 when referencing this establishment in official correspondence.