Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008974316

FEI Number

3008974316

Entity Name

NEOS SURGERY S.L.

City/State/Country

Cerdanyola del Vallès Barcelona, ES

Establishment Address

Parc Tecnològic del Vallès, C/Ceramistes, 2, Cerdanyola del Vallès Barcelona 08290, ES

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Neos Surgery S.L. (Owner Number: 10036243)

Owner / Operator Contact Address

P. Mikeletegi, 2, Donostia, Gipuzkoa, ES-SS 20009, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221795

PMA Number

N/A

All Registered Proprietary Names

Cranial Loop - Cranial Bone Fixation System Cranial COVER SCI0000- Depth gauge, SCI0300- Retractor, SCI0501- Forceps, SCI0700- Cutter_ Kerrison STERN FIX Sternal Stabilization System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2013-10-21
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2016-06-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-12-21
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2023-04-26

Official Correspondent

Eduard Garcia

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

Neos Surgery S.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
K874919	Orthomet, Inc.	ORTHOMET WIRE FOR SUTURE, CERCLAGE	1988-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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1000606483	MCI MEDICAL CONCEPT INNOVATION INC.	Sunrise, FL, US
1825034	BIOMET, INC.	WARSAW, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008974316. Last updated year: 2026. Please use registration number 3008974316 when referencing this establishment in official correspondence.