The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal System.
| Device ID | K070368 |
| 510k Number | K070368 |
| Device Name: | TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Simona Voic |
| Correspondent | Simona Voic STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-08 |
| Decision Date | 2007-05-04 |
| Summary: | summary |