Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020162561

FEI Number

3020162561

Entity Name

BIOCORE9 LLC

City/State/Country

Denville, NJ, US

Establishment Address

30 Broad Street, Ste 3 B, Denville, NJ 07834, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biocore9 LLC (Owner Number: 10082626)

Owner / Operator Contact Address

30 Broad Street, Ste 3 B, Denville, NJ 07834, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193122

PMA Number

N/A

All Registered Proprietary Names

Biocore9 Acetabular Cup System Biocore9 Femoral Head Resurfacing Component Biocore9 Humeral Head Resurfacing System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-12-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2023-12-29
KXA	Prosthesis, Hip, Femoral, Resurfacing	Orthopedic	Class 2	888.3400	2021-08-27
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-08-27

Official Correspondent

Stan Matlak

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biocore9 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
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K940328	Orthopaedic Innovations, Inc.	PRIME CEMENTED HIP SYSTEM	1995-04-07
K950761	Biomet, Inc.	INDEX ACETABULAT COMPONENT	1995-05-02
K972928	Howmedica, Inc.	KERBOULL CROSS	1997-11-03

Similar Registrations

Registration Number	Establishment Name	Location
3012329926	UNITED ORTHOPEDIC CORPORATION	Hsinchu, TW
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
1526534	Sterigenics US, LLC	Lewis Center, OH, US
3020155054	SHALBY ADVANCED TECHNOLOGIES, INC.	El Dorado Hills, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020162561. Last updated year: 2026. Please use registration number 3020162561 when referencing this establishment in official correspondence.