The following data is part of a premarket notification filed by Scien'tx Usa Inc. with the FDA for Modification To Isobar Spinal System.
| Device ID | K020245 |
| 510k Number | K020245 |
| Device Name: | MODIFICATION TO ISOBAR SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SCIEN'TX USA INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Joanna Droege |
| Correspondent | Joanna Droege SCIEN'TX USA INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-24 |
| Decision Date | 2002-02-01 |
| Summary: | summary |