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)

Spine Wave Navigated Instruments

K-Number: K181596 · 2018-10-24

ApplicantSpine Wave, Inc.
Decision Date2018-10-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spine Wave Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K181596. 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 Spine Wave Navigated Instruments?

Spine Wave Navigated Instruments is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Spine Wave, Inc.. The 510(k) number is K181596.

When did Spine Wave Navigated Instruments receive FDA 510(k) clearance?

Spine Wave Navigated Instruments received FDA 510(k) clearance on 2018-10-24, under 510(k) number K181596.

Who is the listed applicant for Spine Wave Navigated Instruments?

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

What is the FDA product code for Spine Wave Navigated Instruments?

The FDA product code for Spine Wave Navigated Instruments is OLO.

Other records listing Spine Wave, 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.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemK261159Exceed® Biplanar Expandable Interbody SystemK243816Testa TP Pivoting Spacer SystemK251131Annex® 2 Adjacent Level SystemK243514Salvo® Robotic Navigation InstrumentsK240685Salvo® Spine System

View all 24 devices →

Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS 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.

↑