AVS® AL And ALign PEEK Spacers, AVS® PL And UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL And PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

STRYKER CORPORATION

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Avs® Al And Align Peek Spacers, Avs® Pl And Unilif Peek Spacers, Avs® Tl Peek Spacer, Avs® Navigator Peek Spacer, Avs® Aria Peek Spacer, Acculif Tl And Pl Cage, Avs® Anchor-l Spacer, Aero-al Lumbar Cage System.

Pre-market Notification Details

Device IDK143163
510k NumberK143163
Device Name:AVS® AL And ALign PEEK Spacers, AVS® PL And UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL And PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
ContactGarry T Hayeck
CorrespondentGarry T Hayeck
STRYKER CORPORATION 2 PEARL COURT Allendale,  NJ  07401
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-03
Decision Date2015-01-26
Summary:summary

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