FDA 510(k)

Navigated Anterolateral Disc Prep Instruments

K-Number: K192336 · 2019-11-22

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2019-11-22

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Navigated Anterolateral Disc Prep Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K192336. 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 Navigated Anterolateral Disc Prep Instruments?

Navigated Anterolateral Disc Prep Instruments is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K192336.

When did Navigated Anterolateral Disc Prep Instruments receive FDA 510(k) clearance?

Navigated Anterolateral Disc Prep Instruments received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192336.

Who is the listed applicant for Navigated Anterolateral Disc Prep Instruments?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navigated Anterolateral Disc Prep Instruments?

The FDA product code for Navigated Anterolateral Disc Prep Instruments is OLO.

Other records listing Medtronic Sofamor Danek USA, 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.

PMA P000058Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction PMA P000054Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction K253011Catalyft PL Expandable Interbody System K261020Symmetrix™ L Spinal System K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System

View all 82 devices →

Related Devices (Code: OLO)

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics K261852OTS HipOrtoma AB

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.