The following data is part of a premarket notification filed by Scient'x Usa, Inc. with the FDA for Scient'x Tribeca Vbr.
| Device ID | K080588 |
| 510k Number | K080588 |
| Device Name: | SCIENT'X TRIBECA VBR |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SCIENT'X USA, INC. 1015 MAITLAND CENTER COMMONS SUITE 106A Maitland, FL 32751 |
| Contact | John Sanders |
| Correspondent | John Sanders SCIENT'X USA, INC. 1015 MAITLAND CENTER COMMONS SUITE 106A Maitland, FL 32751 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-05-30 |
| Summary: | summary |