FDA 510(k)

LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS

K-Number: K113559 · 2011-12-29

Decision Date2011-12-29

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2011-12-29 under 510(k) number K113559. 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 LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS?

LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS is a medical device that received FDA 510(k) clearance on 2011-12-29. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K113559.

When did LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS receive FDA 510(k) clearance?

LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS received FDA 510(k) clearance on 2011-12-29, under 510(k) number K113559.

Who is the listed applicant for LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS?

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

What is the FDA product code for LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS?

The FDA product code for LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS is ODP.

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Other records listing Ldr Spine USA, Inc. as applicant

K162133VerteFIT Corpectomy Cage System K161173Avenue® T TLIF Cage K161798FacetBRIDGE® System K123134EASYSPINE SYSTEM K121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S K113285LDR SPINE USA AVENUE L INTERBODY FUSION

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Related Devices (Code: ODP)

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 Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX 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.