FDA 510(k)

S128 Anterior Lumbar Interbody Fusion (ALIF) System

K-Nummer: K180502 · 2018-06-14

AntragstellerRenovis Surgical Technologies, Inc.

Entscheidungsdatum2018-06-14

ProduktcodeOVD

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: OVD)

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA Innovasis K261408SABER-XA SystemElevation Spine K261809Interwedge® Standalone LateralFoundation Surgical Group K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS DeckplatteTyber Medical, LLC K254202MectaLIF 3D Metal AnteriorMedacta International S.A.

Offizielle Quelle

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