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FDA 510(k)

VAULT-C INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K132029 · 2013-11-25

ApplicantSpinal USA
Decision Date2013-11-25
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VAULT-C INTERVERTEBRAL BODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spinal USA. It received FDA 510(k) clearance on 2013-11-25 under 510(k) number K132029. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAULT-C INTERVERTEBRAL BODY FUSION DEVICE?

VAULT-C INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2013-11-25. The listed applicant is Spinal USA. The 510(k) number is K132029.

When did VAULT-C INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

VAULT-C INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2013-11-25, under 510(k) number K132029.

Who is the listed applicant for VAULT-C INTERVERTEBRAL BODY FUSION DEVICE?

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-C INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for VAULT-C INTERVERTEBRAL BODY FUSION DEVICE is OVE.

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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.

K130863FACET SCREW SYSTEMK131343REFORM PEDICLE SCREW SYSTEMK130279REFORM PEDICLE SCREW SYSTEMK130445VAULT ALIF SYSTEMK122931S-LOK PSS SYSTEMK121172REFORM PEDICLE SCREW SYSTEM

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Related Devices (Code: OVE)

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.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, 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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