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FDA 510(k)

K7C SPACER

K-Number: K123388 · 2013-01-04

ApplicantK7, LLC
Decision Date2013-01-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K7C SPACER is the device name listed in this FDA 510(k) record. The listed applicant is K7, LLC. It received FDA 510(k) clearance on 2013-01-04 under 510(k) number K123388. 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 K7C SPACER?

K7C SPACER is a medical device that received FDA 510(k) clearance on 2013-01-04. The listed applicant is K7, LLC. The 510(k) number is K123388.

When did K7C SPACER receive FDA 510(k) clearance?

K7C SPACER received FDA 510(k) clearance on 2013-01-04, under 510(k) number K123388.

Who is the listed applicant for K7C SPACER?

The FDA 510(k) record lists K7, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K7C SPACER?

The FDA product code for K7C SPACER 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 K7, 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.

K133126K7 LUMBAR SPACERS

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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