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)

NAVIGATION PIN

K-Number: K131130 · 2013-07-19

ApplicantEvergreen Orthopedic Research Lab
Decision Date2013-07-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NAVIGATION PIN is the device name listed in this FDA 510(k) record. The listed applicant is Evergreen Orthopedic Research Lab. It received FDA 510(k) clearance on 2013-07-19 under 510(k) number K131130. 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 NAVIGATION PIN?

NAVIGATION PIN is a medical device that received FDA 510(k) clearance on 2013-07-19. The listed applicant is Evergreen Orthopedic Research Lab. The 510(k) number is K131130.

When did NAVIGATION PIN receive FDA 510(k) clearance?

NAVIGATION PIN received FDA 510(k) clearance on 2013-07-19, under 510(k) number K131130.

Who is the listed applicant for NAVIGATION PIN?

The FDA 510(k) record lists Evergreen Orthopedic Research Lab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NAVIGATION PIN?

The FDA product code for NAVIGATION PIN is OLO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Evergreen Orthopedic Research Lab 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.

K102215KIRSCHNER WIRES, STEINMAN PINS

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.

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLCK261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

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.

↑