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FDA 510(k)

CALIX SPINAL IMPLANT SYSTEM

K-Number: K083637 · 2009-04-20

ApplicantX-Spine Systems, Inc.
Decision Date2009-04-20
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALIX SPINAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2009-04-20 under 510(k) number K083637. 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 CALIX SPINAL IMPLANT SYSTEM?

CALIX SPINAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-20. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K083637.

When did CALIX SPINAL IMPLANT SYSTEM receive FDA 510(k) clearance?

CALIX SPINAL IMPLANT SYSTEM received FDA 510(k) clearance on 2009-04-20, under 510(k) number K083637.

Who is the listed applicant for CALIX SPINAL IMPLANT SYSTEM?

The FDA 510(k) record lists X-Spine Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALIX SPINAL IMPLANT SYSTEM?

The FDA product code for CALIX SPINAL IMPLANT SYSTEM is ODP.

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Other records listing X-Spine Systems, Inc. as applicant

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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

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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