Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012028003

FEI Number

3012028003

Entity Name

ORCHID ORTHOPEDICS SWITZERLAND GMBH

City/State/Country

Baden-Daettwil Aargau, CH

Establishment Address

Taefernstrasse 39, Baden-Daettwil Aargau 5405, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Orchid Orthopedics Switzerland GmbH (Owner Number: 10052580)

Owner / Operator Contact Address

1365 N. Cedar Street, Mason, MI 48854, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

2647346

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2016-08-22
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2016-08-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-09-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-10-31
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-10-31

Official Correspondent

Monica Gonzales

US Agent Details

Monica Gonzales Email: Ray.Maroofian@orchid-ortho.com Phone: (989) 5999191

Related Public Records

Same Entity

Orchid Orthopedics Switzerland GmbH

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
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012028003. Last updated year: 2026. Please use registration number 3012028003 when referencing this establishment in official correspondence.