The following data is part of a premarket notification filed by Scien'tx Usa Inc. with the FDA for Isobar Semi-rigid Spinal System.
Device ID | K991326 |
510k Number | K991326 |
Device Name: | ISOBAR SEMI-RIGID SPINAL SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | SCIEN'TX USA INC. 9800 METRIC BLVD. Austin, TX 78758 |
Contact | Debbie De Los Santos |
Correspondent | Debbie De Los Santos SCIEN'TX USA INC. 9800 METRIC BLVD. Austin, TX 78758 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-19 |
Decision Date | 1999-11-08 |
Summary: | summary |