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)

PISCES-SA Standalone ALIF Interbody System

K-Number: K213935 · 2022-05-06

ApplicantOsseus Fusion Systems
Decision Date2022-05-06
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 2022-05-06 under approval number K213935. 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 2022-05-06. It is manufactured by Osseus Fusion Systems. The 510(k) number is K213935.

When was PISCES-SA Standalone ALIF Interbody System approved by the FDA?

PISCES-SA Standalone ALIF Interbody System received FDA 510(k) clearance on 2022-05-06, under approval number K213935.

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 K223413Pisces™-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.

↑