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)

FUSE Pedicle Screw System

K-Number: K182283 · 2018-10-23

ApplicantBlack Box Medical
Decision Date2018-10-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FUSE Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Black Box Medical. It received FDA 510(k) clearance on 2018-10-23 under 510(k) number K182283. 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 FUSE Pedicle Screw System?

FUSE Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-10-23. The listed applicant is Black Box Medical. The 510(k) number is K182283.

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

FUSE Pedicle Screw System received FDA 510(k) clearance on 2018-10-23, under 510(k) number K182283.

Who is the listed applicant for FUSE Pedicle Screw System?

The FDA 510(k) record lists Black Box Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Black Box Medical 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.

K201751Pedicle Screw SystemK181554Stowe Pedicle Screw System

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.

↑