The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Bone Fixation System.
| Device ID | K040860 |
| 510k Number | K040860 |
| Device Name: | INTEGRA BONE FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Donna R Wallace |
| Correspondent | Donna R Wallace INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HRS |
| Subsequent Product Code | GXN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-06-17 |
| Summary: | summary |