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FDA 510(k)

S128 Anterior Lumbar Interbody Fusion (ALIF) System

K-Number: K180502 · 2018-06-14

ApplicantRenovis Surgical Technologies, Inc.
Decision Date2018-06-14
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S128 Anterior Lumbar Interbody Fusion (ALIF) System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K180502. 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 S128 Anterior Lumbar Interbody Fusion (ALIF) System?

S128 Anterior Lumbar Interbody Fusion (ALIF) System is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Renovis Surgical Technologies, Inc.. The 510(k) number is K180502.

When did S128 Anterior Lumbar Interbody Fusion (ALIF) System receive FDA 510(k) clearance?

S128 Anterior Lumbar Interbody Fusion (ALIF) System received FDA 510(k) clearance on 2018-06-14, under 510(k) number K180502.

Who is the listed applicant for S128 Anterior Lumbar Interbody Fusion (ALIF) System?

The FDA 510(k) record lists Renovis Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S128 Anterior Lumbar Interbody Fusion (ALIF) System?

The FDA product code for S128 Anterior Lumbar Interbody Fusion (ALIF) System is OVD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITINGNCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT048238583Spine Lumbar Fusion Real World Evidence StudyACTIVE_NOT_RECRUITINGNCT05237908Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK CagesACTIVE_NOT_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITINGNCT05583864Lumbar Fusion With Porous Versus Non-Porous CagesACTIVE_NOT_RECRUITING

Other records listing Renovis Surgical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemK182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemK181655Renovis S180 Lateral Lumbar Interbody Fusion SystemK171543Renovis Surgical Hip Replacement SystemK170888Renovis S141 Lumbar Interbody Fusion SystemK153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

View all 7 devices →

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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