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)

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

K-Number: K251154 · 2025-06-12

ApplicantHt Medical D.B.A. Xenix Medical
Decision Date2025-06-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251154. 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 RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Ht Medical D.B.A. Xenix Medical. The 510(k) number is K251154.

When did RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments receive FDA 510(k) clearance?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251154.

Who is the listed applicant for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA 510(k) record lists Ht Medical D.B.A. Xenix Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is NKB.

Other records listing Ht Medical D.B.A. Xenix 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.

K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalK231829Xenix Medical Sacroiliac Fixation 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.

↑