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FDA 510(k)

Pisces™-SA STANDALONE ALIF Interbody System

K-Number: K223413 · 2023-02-10

ApplicantOsseus Fusion Systems
Decision Date2023-02-10
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pisces™-SA STANDALONE ALIF Interbody System is a medical device manufactured by Osseus Fusion Systems. It received FDA 510(k) clearance on 2023-02-10 under approval number K223413. 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 Pisces™-SA STANDALONE ALIF Interbody System?

Pisces™-SA STANDALONE ALIF Interbody System is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Osseus Fusion Systems. The 510(k) number is K223413.

When was Pisces™-SA STANDALONE ALIF Interbody System approved by the FDA?

Pisces™-SA STANDALONE ALIF Interbody System received FDA 510(k) clearance on 2023-02-10, under approval number K223413.

What company makes Pisces™-SA STANDALONE ALIF Interbody System?

Pisces™-SA STANDALONE ALIF Interbody System is manufactured by Osseus Fusion Systems.

What is the FDA product code for Pisces™-SA STANDALONE ALIF Interbody System?

The FDA product code for Pisces™-SA STANDALONE ALIF 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 NCT07526818 Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator. ACTIVE_NOT_RECRUITING

Other Devices by Osseus Fusion Systems

K192121Black Diamond Pedicle Screw System K192495Black Diamond Navigation Instruments K222107Black Diamond™ POCT Spinal System K213935PISCES-SA Standalone ALIF Interbody System

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.

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