The following data is part of a premarket notification filed by Corelink Llc with the FDA for Tiger Spine System.
| Device ID | K133369 |
| 510k Number | K133369 |
| Device Name: | TIGER SPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | CORELINK LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J D Webb |
| Correspondent | J D Webb CORELINK LLC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| 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 | 2013-11-01 |
| Decision Date | 2014-01-14 |
| Summary: | summary |