The following data is part of a premarket notification filed by Scien'tx Usa Inc. with the FDA for Isobar Spinal System.
Device ID | K013444 |
510k Number | K013444 |
Device Name: | 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 | 2001-10-17 |
Decision Date | 2001-11-16 |
Summary: | summary |