SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF
Intervertebral Fusion Device With Bone Graft, Lumbar
SpineVision S.A.
The following data is part of a premarket notification filed by Spinevision S.a. with the FDA for Spacevision® Plif, Spacevision® Olif, Spacevision® Tlif.
Pre-market Notification Details
| Device ID | K153783 |
| 510k Number | K153783 |
| Device Name: | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SpineVision S.A. 10 Rue De La Renaissance, Batment E Antony, FR 92160 |
| Contact | Helene Plas |
| Correspondent | Sylvain Cavailles SpineVision S.A. 10 Rue De La Renaissance, Batiment E Antony, FR 92160 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-31 |
| Decision Date | 2016-05-04 |
| Summary: | summary |
Trademark Results [SpaceVision]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPACEVISION 78338478 2917356 Live/Registered |
Spinevision S.A. 2003-12-09 |
 SPACEVISION 72442408 0990111 Dead/Expired |
SPACEVISION, INC. 1972-11-29 |
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