AVS PL PEEK SPACERS

Intervertebral Fusion Device With Bone Graft, Lumbar

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Avs Pl Peek Spacers.

Pre-market Notification Details

Device IDK093704
510k NumberK093704
Device Name:AVS PL PEEK SPACERS
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
ContactKimberly Lane
CorrespondentKimberly Lane
STRYKER CORP. 2 PEARL COURT Allendale,  NJ  07401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-01
Decision Date2009-12-23
Summary:summary

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