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FDA 510(k)

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System

K-Number: K230808 · 2023-04-21

ApplicantKyocera Medical Technologies, Inc.
Decision Date2023-04-21
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is a medical device manufactured by Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2023-04-21 under approval number K230808. 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 PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System?

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is a medical device that received FDA 510(k) clearance on 2023-04-21. It is manufactured by Kyocera Medical Technologies, Inc.. The 510(k) number is K230808.

When was PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System approved by the FDA?

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System received FDA 510(k) clearance on 2023-04-21, under approval number K230808.

What company makes PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System?

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is manufactured by Kyocera Medical Technologies, Inc..

What is the FDA product code for PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System?

The FDA product code for PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System is OVD.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Kyocera Medical Technologies, Inc.

K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K200709Kyocera Bipolar Hip System K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System K212070KMTI S141 Lumbar Interbody Fusion System K203472KMTI Hip Replacement System

View all 15 devices →

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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