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FDA 510(k)

SPINESMITH CIMPLICITY SPINAL SYSTEM

K-Number: K080971 · 2008-07-02

ApplicantSpine Smith Partners L.P.
Decision Date2008-07-02
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINESMITH CIMPLICITY SPINAL SYSTEM 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 2008-07-02 under 510(k) number K080971. 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 SPINESMITH CIMPLICITY SPINAL SYSTEM?

SPINESMITH CIMPLICITY SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-02. The listed applicant is Spine Smith Partners L.P.. The 510(k) number is K080971.

When did SPINESMITH CIMPLICITY SPINAL SYSTEM receive FDA 510(k) clearance?

SPINESMITH CIMPLICITY SPINAL SYSTEM received FDA 510(k) clearance on 2008-07-02, under 510(k) number K080971.

Who is the listed applicant for SPINESMITH CIMPLICITY SPINAL SYSTEM?

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 SPINESMITH CIMPLICITY SPINAL SYSTEM?

The FDA product code for SPINESMITH CIMPLICITY SPINAL SYSTEM is MQP.

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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 SYSTEMK122168VISUALIF CHALLENGING ACCESS PLATEK102090SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEMK101085SPINESMITH CYNCH SPINAL SYSTEMK090376SPINESMITH CYNCH SPINAL SYSTEMK082821SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE 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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