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)

BIO-RAY A-1 Anchor Screw System

K-Number: K182929 · 2019-11-06

ApplicantMicroware Precision Co., Ltd.
Decision Date2019-11-06
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-RAY A-1 Anchor Screw System is a medical device manufactured by Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2019-11-06 under approval number K182929. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-RAY A-1 Anchor Screw System?

BIO-RAY A-1 Anchor Screw System is a medical device that received FDA 510(k) clearance on 2019-11-06. It is manufactured by Microware Precision Co., Ltd.. The 510(k) number is K182929.

When was BIO-RAY A-1 Anchor Screw System approved by the FDA?

BIO-RAY A-1 Anchor Screw System received FDA 510(k) clearance on 2019-11-06, under approval number K182929.

What company makes BIO-RAY A-1 Anchor Screw System?

BIO-RAY A-1 Anchor Screw System is manufactured by Microware Precision Co., Ltd..

What is the FDA product code for BIO-RAY A-1 Anchor Screw System?

The FDA product code for BIO-RAY A-1 Anchor Screw System is OAT.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07581977 A Novel Two-Tooth Clip for ESD and EFTR of GIST RECRUITING NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology 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 NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by Microware Precision Co., Ltd.

K171904Tandry Locking Plate System K220360Tandry CMF Plate System K220359Tandry Compression Screw System K230690Tandry Locking Plate System K242814Tandry Q-Locking Plate System

Related Devices (Code: OAT)

K161197Orthodontic ScrewOsstem Implant Co., Ltd. K152297OBS Anchorage ScrewBomei Co, Ltd. K161335Dual Top Screw SystemJeil Medical Corporation K173623Anchor plateBiomaterials Korea, Inc. K181142Absoanchor MicroimplantDentos, Inc. K201919Blue Sky Bio TADBlue Sky Bio, LLC

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.

↑