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FDA 510(k)

ShurFit CpTi-HA ACIF Interbody Fusion System

K-Number: K161809 · 2016-12-06

ApplicantPrecision Spine, Inc.
Decision Date2016-12-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ShurFit CpTi-HA ACIF Interbody Fusion System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2016-12-06 under approval number K161809. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShurFit CpTi-HA ACIF Interbody Fusion System?

ShurFit CpTi-HA ACIF Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-12-06. It is manufactured by Precision Spine, Inc.. The 510(k) number is K161809.

When was ShurFit CpTi-HA ACIF Interbody Fusion System approved by the FDA?

ShurFit CpTi-HA ACIF Interbody Fusion System received FDA 510(k) clearance on 2016-12-06, under approval number K161809.

What company makes ShurFit CpTi-HA ACIF Interbody Fusion System?

ShurFit CpTi-HA ACIF Interbody Fusion System is manufactured by Precision Spine, Inc..

What is the FDA product code for ShurFit CpTi-HA ACIF Interbody Fusion System?

The FDA product code for ShurFit CpTi-HA ACIF Interbody Fusion System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Precision Spine, Inc.

K162211AccuFit Lateral Plate System K162300Reform® POCT System K160568Precision Spine Interspinous Plate System K173130Reform® Midline Cortical Screw System K171657ShurFit 2C Lumbar Interbody Fusion System K172495Reform® POCT System

View all 17 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated

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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