The following data is part of a premarket notification filed by Met One Technologies with the FDA for Xultan 5.5 Pedicle Screw System.
Device ID | K170108 |
510k Number | K170108 |
Device Name: | Xultan 5.5 Pedicle Screw System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Met One Technologies 154 N. Festival Dr., Ste. F El Paso, TX 79912 |
Contact | Dan Gerbec |
Correspondent | Kenneth C. Maxwell Ii Empirical Testing Corp. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-12 |
Decision Date | 2017-05-02 |
Summary: | summary |