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)

Monterey AL Interbody System

K-Number: K201585 · 2020-08-10

ApplicantStryker Corporation
Decision Date2020-08-10
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Monterey AL Interbody System is a medical device manufactured by Stryker Corporation. It received FDA 510(k) clearance on 2020-08-10 under approval number K201585. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monterey AL Interbody System?

Monterey AL Interbody System is a medical device that received FDA 510(k) clearance on 2020-08-10. It is manufactured by Stryker Corporation. The 510(k) number is K201585.

When was Monterey AL Interbody System approved by the FDA?

Monterey AL Interbody System received FDA 510(k) clearance on 2020-08-10, under approval number K201585.

What company makes Monterey AL Interbody System?

Monterey AL Interbody System is manufactured by Stryker Corporation.

What is the FDA product code for Monterey AL Interbody System?

The FDA product code for Monterey AL Interbody System is OVD.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Stryker Corporation

K162062AVAmax Vertebral Balloon, AVAflex Vertebral Balloon K160715AccuLIF TL and PL Cage K160978LITe BIO Delivery System K160050SERFAS 90-S Electrosurgical Probe K153407Stryker Neptune 3 Waste Management System K160693Neptune E-SEP Smoke Evacuation Pencil

View all 43 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.

↑