Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008880500

FEI Number

3008880500

Entity Name

ASKORN MEDICAL

City/State/Country

Cesson Sevigne Bretagne, FR

Establishment Address

44c rue de Bray, Cesson Sevigne Bretagne F-35510, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Askorn Medical (Owner Number: 10044425)

Owner / Operator Contact Address

44c rue de Bray, Cesson Sevigne, FR-BRE F-35510, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Universal Tendon Spacer Knee Positioning Device OSSKAR Chirobloc Ring Chirobloc 3 Chirobloc Wrist Chirobloc Ballast Chirobloc Large Chirobloc Small Oxford Concise MCL Retractor Cannulated Compressor PFCC BE POD MEDIO/AR PIED POIGNEE DROITE MINI AO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXA	Prosthesis, Tendon, Passive	Orthopedic	Class 2	888.3025	2025-04-02
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-02-12
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-06-10
LRZ	Screwdriver, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-04-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Askorn Medical

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
K243477	Askorn Medical	Universal Tendon Spacer	2025-01-10
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0040-2018	Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446	1	Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.

Similar Registrations

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3025603301	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Simpang Ampat Pulau Pinang, MY
1061771	TECHNICAL PRODUCTS, INC.	Buford, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008880500. Last updated year: 2026. Please use registration number 3008880500 when referencing this establishment in official correspondence.