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)

FOCUS Pedicle Screw System

K-Number: K180458 · 2018-04-17

ApplicantNvision Biomedical Technologies, LLC
Decision Date2018-04-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOCUS Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K180458. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS Pedicle Screw System?

FOCUS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K180458.

When did FOCUS Pedicle Screw System receive FDA 510(k) clearance?

FOCUS Pedicle Screw System received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180458.

Who is the listed applicant for FOCUS Pedicle Screw System?

The FDA 510(k) record lists Nvision Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOCUS Pedicle Screw System?

The FDA product code for FOCUS Pedicle Screw System is NKB.

Other records listing Nvision Biomedical Technologies, LLC 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.

K253718enHAnce PEEK Bunion SystemK260291Vortex5 Tailor's Bunion Correction SystemK253423ToeJack MIS Bunion SystemK252657Impact PEEK Union Nail SystemK250646Impact PEEK Union Nail SystemK250613SnapHammer Hammertoe Correction System

View all 36 devices →

Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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.

↑