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FDA 510(k)

ANATOMIC PEEK CERVICAL FUSION SYSTEM

K-Number: K112444 · 2011-11-15

ApplicantMedtronic Sofamor Danck USA, Inc.
Decision Date2011-11-15
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANATOMIC PEEK CERVICAL FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danck USA, Inc.. It received FDA 510(k) clearance on 2011-11-15 under 510(k) number K112444. 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 ANATOMIC PEEK CERVICAL FUSION SYSTEM?

ANATOMIC PEEK CERVICAL FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-15. The listed applicant is Medtronic Sofamor Danck USA, Inc.. The 510(k) number is K112444.

When did ANATOMIC PEEK CERVICAL FUSION SYSTEM receive FDA 510(k) clearance?

ANATOMIC PEEK CERVICAL FUSION SYSTEM received FDA 510(k) clearance on 2011-11-15, under 510(k) number K112444.

Who is the listed applicant for ANATOMIC PEEK CERVICAL FUSION SYSTEM?

The FDA 510(k) record lists Medtronic Sofamor Danck USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANATOMIC PEEK CERVICAL FUSION SYSTEM?

The FDA product code for ANATOMIC PEEK CERVICAL FUSION 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 Medtronic Sofamor Danck USA, Inc. 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.

K110070TSRH SPINAL 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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