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FDA 510(k)

VAULT ALIF SYSTEM

K-Number: K130445 · 2013-04-25

ApplicantSpinal USA
Decision Date2013-04-25
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VAULT ALIF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spinal USA. It received FDA 510(k) clearance on 2013-04-25 under 510(k) number K130445. 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 VAULT ALIF SYSTEM?

VAULT ALIF SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-25. The listed applicant is Spinal USA. The 510(k) number is K130445.

When did VAULT ALIF SYSTEM receive FDA 510(k) clearance?

VAULT ALIF SYSTEM received FDA 510(k) clearance on 2013-04-25, under 510(k) number K130445.

Who is the listed applicant for VAULT ALIF SYSTEM?

The FDA 510(k) record lists Spinal USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAULT ALIF SYSTEM?

The FDA product code for VAULT ALIF SYSTEM is OVD.

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Other records listing Spinal USA 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.

K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICEK130863FACET SCREW SYSTEMK131343REFORM PEDICLE SCREW SYSTEMK130279REFORM PEDICLE SCREW SYSTEMK122931S-LOK PSS SYSTEMK121172REFORM PEDICLE SCREW 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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