The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk - Line Extension.
| Device ID | K120790 |
| 510k Number | K120790 |
| Device Name: | GMK - LINE EXTENSION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030823190 | K120790 | 000 |
| 07630030822919 | K120790 | 000 |
| 07630030822926 | K120790 | 000 |
| 07630030822933 | K120790 | 000 |
| 07630030822940 | K120790 | 000 |
| 07630030822957 | K120790 | 000 |
| 07630030822964 | K120790 | 000 |
| 07630030822971 | K120790 | 000 |
| 07630030822988 | K120790 | 000 |
| 07630030822902 | K120790 | 000 |
| 07630030822896 | K120790 | 000 |
| 07630030820281 | K120790 | 000 |
| 07630030820908 | K120790 | 000 |
| 07630030820915 | K120790 | 000 |
| 07630030822841 | K120790 | 000 |
| 07630030822858 | K120790 | 000 |
| 07630030822865 | K120790 | 000 |
| 07630030822872 | K120790 | 000 |
| 07630030822889 | K120790 | 000 |
| 07630030822995 | K120790 | 000 |
| 07630030823008 | K120790 | 000 |
| 07630030823114 | K120790 | 000 |
| 07630030823121 | K120790 | 000 |
| 07630030823138 | K120790 | 000 |
| 07630030823145 | K120790 | 000 |
| 07630030823152 | K120790 | 000 |
| 07630030823169 | K120790 | 000 |
| 07630030823176 | K120790 | 000 |
| 07630030823183 | K120790 | 000 |
| 07630030823107 | K120790 | 000 |
| 07630030823091 | K120790 | 000 |
| 07630030823015 | K120790 | 000 |
| 07630030823022 | K120790 | 000 |
| 07630030823039 | K120790 | 000 |
| 07630030823046 | K120790 | 000 |
| 07630030823053 | K120790 | 000 |
| 07630030823060 | K120790 | 000 |
| 07630030823077 | K120790 | 000 |
| 07630030823084 | K120790 | 000 |
| 07630030820274 | K120790 | 000 |