The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Total Foot Systems.
| Device ID | K123000 |
| 510k Number | K123000 |
| Device Name: | INTEGRA TOTAL FOOT SYSTEMS |
| Classification | Plate, Fixation, Bone |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Stephen H Beier |
| Correspondent | Stephen H Beier INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2012-12-21 |
| Summary: | summary |