Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Mariner Deformity System

K-Number: K211606 · 2021-06-23

ApplicantSeaSpine Orthopedics Corporation
Decision Date2021-06-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mariner Deformity System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-06-23 under approval number K211606. 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 Mariner Deformity System?

Mariner Deformity System is a medical device that received FDA 510(k) clearance on 2021-06-23. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K211606.

When was Mariner Deformity System approved by the FDA?

Mariner Deformity System received FDA 510(k) clearance on 2021-06-23, under approval number K211606.

What company makes Mariner Deformity System?

Mariner Deformity System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Mariner Deformity System?

The FDA product code for Mariner Deformity System is NKB.

Related Clinical Trials

NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Other Devices by SeaSpine Orthopedics Corporation

K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System K161535SeaSpine® NewPort™ Spinal System K160902Mariner Pedicle Screw System K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical

View all 66 devices →

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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.

↑