The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Newgen System.
| Device ID | K002619 |
| 510k Number | K002619 |
| Device Name: | NEWGEN SYSTEM |
| Classification | Plate, Bone |
| Applicant | STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
| Contact | Robin L Rowe |
| Correspondent | Robin L Rowe STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 -6197 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-23 |
| Decision Date | 2000-11-16 |