The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Theken Spine Vu Epod And Vu Lpod System.
| Device ID | K082712 |
| 510k Number | K082712 |
| Device Name: | THEKEN SPINE VU EPOD AND VU LPOD SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-16 |
| Decision Date | 2009-01-02 |
| Summary: | summary |