The following data is part of a premarket notification filed by Neirynck & Vogt Nv with the FDA for Chroloy.
| Device ID | K021969 |
| 510k Number | K021969 |
| Device Name: | CHROLOY |
| Classification | Alloy, Metal, Base |
| Applicant | NEIRYNCK & VOGT NV 12960 STONECREEK DR. Pickerington, OH 43147 |
| Contact | Josh Andrachek |
| Correspondent | Josh Andrachek NEIRYNCK & VOGT NV 12960 STONECREEK DR. Pickerington, OH 43147 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-17 |
| Decision Date | 2002-07-30 |