Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SafeOp 3: Neural Informatix Systeem

K-Number: K234092 · 2024-04-19

ApplicantAlphatec Spine, Inc.
Decision Date2024-04-19
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SafeOp 3: Neural Informatix Systeem is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K234092. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeOp 3: Neural Informatix Systeem?

SafeOp 3: Neural Informatix Systeem is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K234092.

When did SafeOp 3: Neural Informatix Systeem receive FDA 510(k) clearance?

SafeOp 3: Neural Informatix Systeem received FDA 510(k) clearance on 2024-04-19, under 510(k) number K234092.

Who is the listed applicant for SafeOp 3: Neural Informatix Systeem?

The FDA 510(k) record lists Alphatec Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeOp 3: Neural Informatix Systeem?

The FDA product code for SafeOp 3: Neural Informatix Systeem is GWF.

Other records listing Alphatec Spine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemK253216IntraOp Alignment System; CONTOUR3D Bending SystemK253615Invictus Bands SystemK252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix SystemK251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

View all 67 devices →

Related Devices (Code: GWF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx NeuroscienceK234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑