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

FDA 510(k)

Alphatec Navigation Instruments

K-Number: K153603 · 2016-04-29

ApplicantAlphatec Spine, Inc.
Decision Date2016-04-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Alphatec Navigation Instruments is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2016-04-29 under approval number K153603. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alphatec Navigation Instruments?

Alphatec Navigation Instruments is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K153603.

When was Alphatec Navigation Instruments approved by the FDA?

Alphatec Navigation Instruments received FDA 510(k) clearance on 2016-04-29, under approval number K153603.

What company makes Alphatec Navigation Instruments?

Alphatec Navigation Instruments is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Alphatec Navigation Instruments?

The FDA product code for Alphatec Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

Other Devices by Alphatec Spine, Inc.

K160646XYcor® Expandable Spinal Spacer System K161363Arsenal Spinal Fixation System K173522Solanas® Posterior Stabilization System K182746ATEC ALIF and LLIF Spacer System K182808Aspida® Anterior Lumbar Plating System K181980OsseoScrew System

View all 59 devices →

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

↑