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FDA 510(k)

LDR SPINE USA AVENUE L INTERBODY FUSION

K-Number: K113285 · 2012-07-26

ApplicantLdr Spine USA, Inc.
Decision Date2012-07-26
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LDR SPINE USA AVENUE L INTERBODY FUSION 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 2012-07-26 under 510(k) number K113285. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDR SPINE USA AVENUE L INTERBODY FUSION?

LDR SPINE USA AVENUE L INTERBODY FUSION is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K113285.

When did LDR SPINE USA AVENUE L INTERBODY FUSION receive FDA 510(k) clearance?

LDR SPINE USA AVENUE L INTERBODY FUSION received FDA 510(k) clearance on 2012-07-26, under 510(k) number K113285.

Who is the listed applicant for LDR SPINE USA AVENUE L INTERBODY FUSION?

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 USA AVENUE L INTERBODY FUSION?

The FDA product code for LDR SPINE USA AVENUE L INTERBODY FUSION is OVD.

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Other records listing Ldr Spine 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.

K162133VerteFIT Corpectomy Cage SystemK161173Avenue® T TLIF CageK161798FacetBRIDGE® SystemK123134EASYSPINE SYSTEMK121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT SK120760LDR SPINE SPINETUNE TL SPINAL SYSTEM

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Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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