The following data is part of a premarket notification filed by Scient'x with the FDA for Isobar Semi-rigid Dual Dampener.
| Device ID | K071261 |
| 510k Number | K071261 |
| Device Name: | ISOBAR SEMI-RIGID DUAL DAMPENER |
| Classification | Posterior Metal/polymer Spinal System, Fusion |
| Applicant | SCIENT'X 1015 MAITLAND CENTER COMMONS SUITE 106A Maitland, FL 32751 |
| Contact | John Sanders |
| Correspondent | John Sanders SCIENT'X 1015 MAITLAND CENTER COMMONS SUITE 106A Maitland, FL 32751 |
| Product Code | NQP |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-04 |
| Decision Date | 2008-04-17 |
| Summary: | summary |