The following data is part of a premarket notification filed by Spinal Balance, Inc. with the FDA for Libra Pedicle Screw System.
| Device ID | K162750 |
| 510k Number | K162750 |
| Device Name: | Libra Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Spinal Balance, Inc. 1510 North Westwood Avenue Toledo, OH 43606 |
| Contact | Anand Agarwal |
| Correspondent | Karen E. Warden BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 -0566 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2016-10-27 |
| Summary: | summary |