Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013546462

FEI Number

3013546462

Entity Name

NEO MEDICAL S.A.

City/State/Country

Villette (Lavaux) Vaud, CH

Establishment Address

Route de Lausanne 157A, Villette (Lavaux) Vaud 1096, CH

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neo Medical S.A. (Owner Number: 10054814)

Owner / Operator Contact Address

Route de Lausanne 157A, Villette (Lavaux), CH-VD 1096, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222256

PMA Number

N/A

All Registered Proprietary Names

NEO Pedicle Screw System Neo Cage System Neo Pedicle Screw System Screwdriver Handle, NS Screwdriver Adaptor - 1/4", NS Screwdriver Adaptor - AO, NS Screwdriver Converter - AO, NS Ratchet Handle - 1/4", NS Screwdriver Converter - Hudson, NS Screwdriver Adaptor - Hudson, NS Ratchet Screwdriver ¼, NS Screwdriver kit Set screwdriver Ratchet Handle - Hudson, NS Set-screwdriver (10x1) Neo Pedicle Screw System Neo Pedicle Screw System NEO Pedicle Screw System Tap kit for Neo Pedicle Screw System Cement Pusher MIS Posterior retractor lateral blade kit 70mm MIS Posterior retractor lateral blade kit 40mm MIS Posterior retractor access kit Lateral retractor kit 180mm Lateral retractor kit 120mm Posterior retractor kit 70mm Posterior retractor access kit Lateral retractor access kit Posterior retractor kit 40mm Posterior retractor kit 50mm Posterior retractor kit 60mm Lateral retractor kit 160mm MIS Posterior retractor kit 80mm Posterior retractor kit 80mm Lateral retractor kit 140mm MIS Posterior retractor lateral blade kit 90mm MIS Posterior retractor lateral blade kit 50mm MIS Posterior retractor lateral blade kit 60mm MIS Posterior retractor lateral blade kit 80mm MIS Posterior retractor kit 70mm MIS Posterior retractor kit 40mm MIS Posterior retractor kit 50mm MIS Posterior retractor kit 60mm Rod Bender NS Neo Flex Light Compressor Distractor Kit Revision Guide (10x1) Ratchet T-Handle - 1/4", NS Cage puller Cage Bent Curette Kit Persuader Non-constraint torque limiter (10x) Cage holder Revision Guide Scraper / distractor Rod Rotation Wrench Cage Instrument Kit Pedicle marker Cage straight curette kit Pedicle Screw Instrument Kit T-Handle Kit Non-constraint torque limiter Posterior instrument kit Cage Pusher Kit Marker Base (10x1) Removal Kit Single Use Pedicle marker (2x) K-wire Kit Screw Guide Remover Neo Cage System Neo Pedicle Screw System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2021-11-03
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-11-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-11-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-12-30
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-10-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-10-08
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-01-13
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2025-01-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-13
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2021-11-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-11-03
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-11-03
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2021-11-03
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-05-04
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2021-09-02
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-01-17
HXW	Bender	Orthopedic	Class 1	888.4540	2024-01-17
FSQ	Light, Surgical, Instrument	General, Plastic Surgery	Class 2	878.4580	2026-06-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-10-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2019-02-11
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2022-09-09
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2022-09-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-09-09

Official Correspondent

No official correspondent registered.

US Agent Details

Alfred Lerch Business: confinis USA Inc. Email: usagent@confinis.com Phone: (910) 2289391

Related Public Records

Same Entity

Neo Medical S.A.

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
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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3008572623	ELMDOWN SRL UNIPERSONALE	milano Lombardy, IT
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013546462. Last updated year: 2026. Please use registration number 3013546462 when referencing this establishment in official correspondence.