The following data is part of a premarket notification filed by Corelink Llc with the FDA for Tiger Spine System.
| Device ID | K120696 |
| 510k Number | K120696 |
| Device Name: | TIGER SPINE SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-07 |
| Decision Date | 2012-04-02 |
| Summary: | summary |