The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Vu Apod Intervertabral Body Fusion Device.
Device ID | K080822 |
510k Number | K080822 |
Device Name: | VU APOD INTERVERTABRAL BODY FUSION DEVICE |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306 |
Contact | Dale Davison |
Correspondent | Dale Davison THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron, OH 44306 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-24 |
Decision Date | 2008-07-02 |
Summary: | summary |