NEO SPINE USA INC.

FDA Device Registration & Listing · Hackensack, NJ, US · Registration 3014003062

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014003062
FEI Number
3014003062
Entity Name
NEO SPINE USA INC.
City/State/Country
Hackensack, NJ, US
Establishment Address
411 Hackensack Avenue #200-126, Hackensack, NJ 07601, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Neo Spine USA Inc. (Owner Number: 10056088)
Owner / Operator Contact Address
411 Hackensack Avenue #200-126, Hackensack, NJ 07601, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Neo Pedicle Screw System Sterile container Tap kit for Neo Pedicle Screw System Neo Pedicle Screw System Neo Flex Light Cement pusher NEO Pedicle Screw System Neo Pedicle Screw System Screwdriver Adaptor - 1/4", NS Ratchet Handle - 1/4", NS Ratchet Handle - Hudson, NS Set screwdriver Screwdriver Converter - Hudson, NS Screwdriver Adaptor - AO, NS Screwdriver Converter - AO, NS Screwdriver Handle, NS Screwdriver kit Ratchet Screwdriver, NS Screwdriver Adaptor - Hudson, NS Set-screwdriver (10x1) MIS Posterior retractor kit 60mm MIS Posterior retractor lateral blade kit 50mm MIS Posterior retractor lateral blade kit 60mm MIS Posterior retractor lateral blade kit 70mm MIS Posterior retractor kit 80mm MIS Posterior retractor access kit Lateral retractor kit 180mm Posterior retractor kit 70mm Posterior retractor kit 60mm Posterior retractor access kit Lateral retractor kit 160mm Lateral retractor access kit Posterior retractor kit 80mm Lateral retractor kit 120mm Lateral retractor kit 140mm Posterior retractor kit 50mm Posterior retractor kit 40mm MIS Posterior retractor lateral blade kit 90mm MIS Posterior retractor kit 70mm MIS Posterior retractor lateral blade kit 40mm MIS Posterior retractor lateral blade kit 80mm MIS Posterior retractor kit 40mm MIS Posterior retractor kit 50mm BonOs Inject NEO Pedicle Screw System Rod Bender NS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-11-05
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-02-23
HWX Tap, Bone Orthopedic Class 1 888.4540 2017-11-05
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2022-12-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-12-09
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2022-12-09
FSQ Light, Surgical, Instrument General, Plastic Surgery Class 2 878.4580 2026-06-15
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2021-09-02
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
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-11-03
HXX Screwdriver Orthopedic Class 1 888.4540 2017-11-05
GAD Retractor General, Plastic Surgery Class 1 878.4800 2024-01-16
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2021-06-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-06-15
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2021-06-15
LOD Bone Cement Orthopedic Class 2 888.3027 2021-06-15
HXW Bender Orthopedic Class 1 888.4540 2024-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neo Spine USA Inc.
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014003062. Last updated year: 2026. Please use registration number 3014003062 when referencing this establishment in official correspondence.
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