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)

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

K-Number: K200792 · 2020-10-05

ApplicantMedacta Inernational SA
Decision Date2020-10-05
Product CodePQC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is a medical device manufactured by Medacta Inernational SA. It received FDA 510(k) clearance on 2020-10-05 under approval number K200792. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is a medical device that received FDA 510(k) clearance on 2020-10-05. It is manufactured by Medacta Inernational SA. The 510(k) number is K200792.

When was MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides approved by the FDA?

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides received FDA 510(k) clearance on 2020-10-05, under approval number K200792.

What company makes MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is manufactured by Medacta Inernational SA.

What is the FDA product code for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

The FDA product code for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is PQC.

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Osseointegrative Technology ENROLLING_BY_INVITATION NCT03404895 The Mount Sinai Diabetic Foot Ulcer Prospective Trial WITHDRAWN NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Medacta Inernational SA

K193175Lateralized Glenosphere K193559NextAR TKA Platform K200551MectaLIF Transforaminal TiPEEK

Related Devices (Code: PQC)

K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc. K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc. K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A. K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A. K231483MySpine Unilateral GuidesMedacta International S.A.

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.

↑