Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036773273

FEI Number

3036773273

Entity Name

Adler Ortho SpA

City/State/Country

Mezzolombardo Trento, IT

Establishment Address

Viale Trento 115/117, Mezzolombardo Trento 38017, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Adler Ortho S.p.A. (Owner Number: 10086224)

Owner / Operator Contact Address

Via Dell'Innovazione 9, Cormano, IT-MI 20032, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CUSTOM MADE HIP PROSTHESIS, UNCEMENTED CUSTOM MADE UPPER FEMORAL PROSTHESIS CUSTOM MADE HIP PROSTHESIS, UNCEMENTED, HA COATED Pantheon Proximal Femur Reconstruction (PFR) System CUSTOM MADE HIP PROSTHESIS, CEMENTED

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	2022-11-16
JDD	Prosthesis, Upper Femoral	Orthopedic	Class 2	888.3360	2024-12-11
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2023-01-26
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2025-01-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2025-01-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-01-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2025-01-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2023-01-27

Official Correspondent

Edgardo Cremascoli

US Agent Details

Albert Nanni Business: Pivot MedTech, LLC Email: ananni@pivotmedtech.com Phone: (856) 2961691

Related Public Records

Same Entity

Adler Ortho S.p.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008281151	ADLER ORTHO S.P.A.	Cormano Milano, IT

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
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

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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 3036773273. Last updated year: 2026. Please use registration number 3036773273 when referencing this establishment in official correspondence.