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 |