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FDA 510(k)

Kalitec Direct InSePtion™ MIS Fixation System

K-Number: K163471 · 2017-03-16

ApplicantKalitec Direct, LLC
Decision Date2017-03-16
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kalitec Direct InSePtion™ MIS Fixation System is a medical device manufactured by Kalitec Direct, LLC. It received FDA 510(k) clearance on 2017-03-16 under approval number K163471. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kalitec Direct InSePtion™ MIS Fixation System?

Kalitec Direct InSePtion™ MIS Fixation System is a medical device that received FDA 510(k) clearance on 2017-03-16. It is manufactured by Kalitec Direct, LLC. The 510(k) number is K163471.

When was Kalitec Direct InSePtion™ MIS Fixation System approved by the FDA?

Kalitec Direct InSePtion™ MIS Fixation System received FDA 510(k) clearance on 2017-03-16, under approval number K163471.

What company makes Kalitec Direct InSePtion™ MIS Fixation System?

Kalitec Direct InSePtion™ MIS Fixation System is manufactured by Kalitec Direct, LLC.

What is the FDA product code for Kalitec Direct InSePtion™ MIS Fixation System?

The FDA product code for Kalitec Direct InSePtion™ MIS Fixation System is PEK.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07586098 AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Kalitec Direct, LLC

K172808CosmoLock Pedicle Screw System K172086Matira™ Anterior Cervical System K170342Ocata Anterior Cervical System K180401TiWAVE-C™ Porous Titanium Cervical Cage

Related Devices (Code: PEK)

K161016Z-Clamp ISP SystemZavation, LLC K153302coflex-IFParadigm Spine, LLC K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd. K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity

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.

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