AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE

Intervertebral Fusion Device With Bone Graft, Lumbar

AESCULAP IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Aesculap Peek Intervertebral Body Fusion System: A Space, Cespace, Prospace, T-space.

Pre-market Notification Details

Device IDK071983
510k NumberK071983
Device Name:AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley,  PA  18034
ContactMatthew M Hull
CorrespondentMatthew M Hull
AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley,  PA  18034
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-19
Decision Date2008-05-01
Summary:summary

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