The following data is part of a premarket notification filed by Corelink Llc with the FDA for Tiger Occipital-cervical-thoracic Spinal Fixation System.
| Device ID | K132504 |
| 510k Number | K132504 |
| Device Name: | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | CORELINK LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton CORELINK LLC 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-11-25 |
| Summary: | summary |