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FDA 510(k)

SPINAL USA VBR SYSTEM

K-Number: K061752 · 2006-08-15

ApplicantSpinal USA
Decision Date2006-08-15
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL USA VBR 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 2006-08-15 under 510(k) number K061752. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL USA VBR SYSTEM?

SPINAL USA VBR SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-15. The listed applicant is Spinal USA. The 510(k) number is K061752.

When did SPINAL USA VBR SYSTEM receive FDA 510(k) clearance?

SPINAL USA VBR SYSTEM received FDA 510(k) clearance on 2006-08-15, under 510(k) number K061752.

Who is the listed applicant for SPINAL USA VBR 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 SPINAL USA VBR SYSTEM?

The FDA product code for SPINAL USA VBR SYSTEM is MQP.

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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 SYSTEMK130445VAULT ALIF SYSTEMK122931S-LOK PSS SYSTEM

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Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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