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FDA 510(k)

SPIRA-C Integrated Fixation System

K-Number: K193153 · 2020-04-24

ApplicantCamber Spine Technologies
Decision Date2020-04-24
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRA-C Integrated Fixation System is a medical device manufactured by Camber Spine Technologies. It received FDA 510(k) clearance on 2020-04-24 under approval number K193153. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRA-C Integrated Fixation System?

SPIRA-C Integrated Fixation System is a medical device that received FDA 510(k) clearance on 2020-04-24. It is manufactured by Camber Spine Technologies. The 510(k) number is K193153.

When was SPIRA-C Integrated Fixation System approved by the FDA?

SPIRA-C Integrated Fixation System received FDA 510(k) clearance on 2020-04-24, under approval number K193153.

What company makes SPIRA-C Integrated Fixation System?

SPIRA-C Integrated Fixation System is manufactured by Camber Spine Technologies.

What is the FDA product code for SPIRA-C Integrated Fixation System?

The FDA product code for SPIRA-C Integrated Fixation System is OVE.

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 NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07579832 Quantitative Monitoring of Disability Care Quality for Long-Term Care Facilities 2 NOT_YET_RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Camber Spine Technologies

K153720ENZA Zero-Profile Anterior Interbody Fusion K172446SPIRA-C Open Matrix Cervical Interbody K172064Ti-Diagon Oblique TLIF K170550Coveris Cervical Cage System K162986SPIRA Open Matrix ALIF K162121Siconus SI Joint Fixation System

View all 16 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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