The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Sphere Extension.
| Device ID | K140826 |
| 510k Number | K140826 |
| Device Name: | GMK SPHERE EXTENSION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MEDACTA INTERNATIONAL 1556 W CARROLL AVE. Chicago, IL 60607 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 1556 W CARROLL AVE. Chicago, IL 60607 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030862717 | K140826 | 000 |
| 07630030862526 | K140826 | 000 |
| 07630030862519 | K140826 | 000 |
| 07630030862502 | K140826 | 000 |
| 07630030862496 | K140826 | 000 |
| 07630030862489 | K140826 | 000 |
| 07630030862472 | K140826 | 000 |
| 07630030862465 | K140826 | 000 |
| 07630030862458 | K140826 | 000 |
| 07630030862441 | K140826 | 000 |
| 07630030862434 | K140826 | 000 |
| 07630030862427 | K140826 | 000 |
| 07630030862410 | K140826 | 000 |
| 07630030862403 | K140826 | 000 |
| 07630030862397 | K140826 | 000 |
| 07630030862380 | K140826 | 000 |
| 07630030862373 | K140826 | 000 |
| 07630030862533 | K140826 | 000 |
| 07630030862540 | K140826 | 000 |
| 07630030862700 | K140826 | 000 |
| 07630030862694 | K140826 | 000 |
| 07630030862687 | K140826 | 000 |
| 07630030862670 | K140826 | 000 |
| 07630030862663 | K140826 | 000 |
| 07630030862656 | K140826 | 000 |
| 07630030862649 | K140826 | 000 |
| 07630030862632 | K140826 | 000 |
| 07630030862625 | K140826 | 000 |
| 07630030862618 | K140826 | 000 |
| 07630030862601 | K140826 | 000 |
| 07630030862595 | K140826 | 000 |
| 07630030862588 | K140826 | 000 |
| 07630030862571 | K140826 | 000 |
| 07630030862564 | K140826 | 000 |
| 07630030862557 | K140826 | 000 |
| 07630030862366 | K140826 | 000 |