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FDA 510(k)

INTEGRITY SPINE CORE SYSTEM

K-Number: K132718 · 2013-11-18

ApplicantIntegrity Spine
Decision Date2013-11-18
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRITY SPINE CORE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Spine. It received FDA 510(k) clearance on 2013-11-18 under 510(k) number K132718. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRITY SPINE CORE SYSTEM?

INTEGRITY SPINE CORE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-18. The listed applicant is Integrity Spine. The 510(k) number is K132718.

When did INTEGRITY SPINE CORE SYSTEM receive FDA 510(k) clearance?

INTEGRITY SPINE CORE SYSTEM received FDA 510(k) clearance on 2013-11-18, under 510(k) number K132718.

Who is the listed applicant for INTEGRITY SPINE CORE SYSTEM?

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

What is the FDA product code for INTEGRITY SPINE CORE SYSTEM?

The FDA product code for INTEGRITY SPINE CORE SYSTEM is ODP.

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 Integrity Spine 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.

K223043The Integrity Spine Core System

Related Devices (Code: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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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