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FDA 510(k)

ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.

K-Number: K060916 · 2006-06-08

ApplicantSpinal Edge, LLC
Decision Date2006-06-08
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Edge, LLC. It received FDA 510(k) clearance on 2006-06-08 under 510(k) number K060916. 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 ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.?

ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. is a medical device that received FDA 510(k) clearance on 2006-06-08. The listed applicant is Spinal Edge, LLC. The 510(k) number is K060916.

When did ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. receive FDA 510(k) clearance?

ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. received FDA 510(k) clearance on 2006-06-08, under 510(k) number K060916.

Who is the listed applicant for ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.?

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

What is the FDA product code for ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017.?

The FDA product code for ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. is MQP.

Related Clinical Trials

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.

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Other records listing Spinal Edge, LLC 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.

K092774ATLAS INTERVERTEBRAL BODY CAGEK091110SPINAL EDGE TITAN PEDICLE SCREW SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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