The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Eclipse Total Ankle Implant.
| Device ID | K061749 |
| 510k Number | K061749 |
| Device Name: | ECLIPSE TOTAL ANKLE IMPLANT |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Contact | John G Stampinato |
| Correspondent | John G Stampinato KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-21 |
| Decision Date | 2006-11-22 |
| Summary: | summary |