The following data is part of a premarket notification filed by Kalitec Direct, Llc with the FDA for Cosmolock Pedicle Screw System.
| Device ID | K172808 |
| 510k Number | K172808 |
| Device Name: | CosmoLock Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Kalitec Direct, LLC 618 E. South Street, Suite 500 Orlando, FL 32801 |
| Contact | Scott Winn |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, TX 78681 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2017-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07310XLV00040 | K172808 | 000 |
| B07310XLF00180 | K172808 | 000 |
| B07310XLF00200 | K172808 | 000 |
| B07310XLF00220 | K172808 | 000 |
| B07310XLF00240 | K172808 | 000 |
| B07310XLF00260 | K172808 | 000 |
| B07310XLF00280 | K172808 | 000 |
| B07310XLF00300 | K172808 | 000 |
| B07310XLF00320 | K172808 | 000 |
| B07310XLF00340 | K172808 | 000 |
| B07310XLF00360 | K172808 | 000 |
| B07310XLF00380 | K172808 | 000 |
| B07310BRS02300 | K172808 | 000 |