AVS AS PEEK Spacer

Intervertebral Fusion Device With Bone Graft, Cervical

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Avs As Peek Spacer.

Pre-market Notification Details

Device IDK142251
510k NumberK142251
Device Name:AVS AS PEEK Spacer
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Stryker Corporation 2 Pearl Court Stryker Spine Division Allendale,  NJ  07401
ContactGarry T Hayeck
CorrespondentGarry T Hayeck
Stryker Corporation 2 Pearl Court Stryker Spine Division Allendale,  NJ  07401
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-14
Decision Date2014-11-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.