The following data is part of a premarket notification filed by Pro-active Healthcare with the FDA for Modification To Esop Co-cr Femoral Heads.
| Device ID | K023375 |
| 510k Number | K023375 |
| Device Name: | MODIFICATION TO ESOP CO-CR FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | PRO-ACTIVE HEALTHCARE 815 CONNECTICUT AVE. NW SUITE 800 Washington, DC 20006 |
| Contact | Andre Weith |
| Correspondent | Andre Weith PRO-ACTIVE HEALTHCARE 815 CONNECTICUT AVE. NW SUITE 800 Washington, DC 20006 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-08 |
| Decision Date | 2002-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489408748 | K023375 | 000 |
| 03661489408663 | K023375 | 000 |
| 03661489408595 | K023375 | 000 |
| 03661489408588 | K023375 | 000 |