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FDA 510(k)

VISUALIF CHALLENGING ACCESS PLATE

K-Number: K122168 · 2012-10-11

ApplicantSpine Smith Partners L.P.
Decision Date2012-10-11
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VISUALIF CHALLENGING ACCESS PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Spine Smith Partners L.P.. It received FDA 510(k) clearance on 2012-10-11 under 510(k) number K122168. 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 VISUALIF CHALLENGING ACCESS PLATE?

VISUALIF CHALLENGING ACCESS PLATE is a medical device that received FDA 510(k) clearance on 2012-10-11. The listed applicant is Spine Smith Partners L.P.. The 510(k) number is K122168.

When did VISUALIF CHALLENGING ACCESS PLATE receive FDA 510(k) clearance?

VISUALIF CHALLENGING ACCESS PLATE received FDA 510(k) clearance on 2012-10-11, under 510(k) number K122168.

Who is the listed applicant for VISUALIF CHALLENGING ACCESS PLATE?

The FDA 510(k) record lists Spine Smith Partners L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISUALIF CHALLENGING ACCESS PLATE?

The FDA product code for VISUALIF CHALLENGING ACCESS PLATE is OVD.

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Other records listing Spine Smith Partners L.P. 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.

K122630IN:C2 SPINAL FIXATION SYSTEMK102090SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEMK101085SPINESMITH CYNCH SPINAL SYSTEMK090376SPINESMITH CYNCH SPINAL SYSTEMK082821SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEMK081132SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

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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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-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.

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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