Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007391088

FEI Number

3007391088

Entity Name

GRUPPO BIOIMPIANTI S.R.L.

City/State/Country

Peschiera Borromeo Milano, IT

Establishment Address

Via Liguria 28, Peschiera Borromeo Milano 20068, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gruppo Bioimpianti S.r.l. (Owner Number: 10051817)

Owner / Operator Contact Address

Via Liguria 28, Peschiera Borromeo, IT-MI 20068, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152903

PMA Number

N/A

All Registered Proprietary Names

Revival Modular Revision Hip Stem

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2016-05-06
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2016-05-06

Official Correspondent

Lucinda Gerber

US Agent Details

Lucinda Gerber Business: Corin USA Email: lucinda.gerber@coringroup.com Phone: (772) 3212478

Related Public Records

Same Entity

Gruppo Bioimpianti S.r.l.

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
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Similar Registrations

Registration Number	Establishment Name	Location
3021386586	LINCOTEK (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
3005562917	BGS Beta-Gamma-Service GmbH & Co KG	Bruchsal Baden-Wurttemberg, DE
1450662	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007391088. Last updated year: 2026. Please use registration number 3007391088 when referencing this establishment in official correspondence.