The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectascrew Extension.
| Device ID | K203335 |
| 510k Number | K203335 |
| Device Name: | MectaScrew Extension |
| Classification | Screw, Fixation, Bone |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2022-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345703422 | K203335 | 000 |
| 07630345703255 | K203335 | 000 |
| 07630345703262 | K203335 | 000 |
| 07630345703279 | K203335 | 000 |
| 07630345703286 | K203335 | 000 |
| 07630345703293 | K203335 | 000 |
| 07630345703309 | K203335 | 000 |
| 07630345703316 | K203335 | 000 |
| 07630345703323 | K203335 | 000 |
| 07630345703330 | K203335 | 000 |
| 07630345703347 | K203335 | 000 |
| 07630345703354 | K203335 | 000 |
| 07630345703361 | K203335 | 000 |
| 07630345703378 | K203335 | 000 |
| 07630345703385 | K203335 | 000 |
| 07630345703392 | K203335 | 000 |
| 07630345703408 | K203335 | 000 |
| 07630345703415 | K203335 | 000 |
| 07630345703248 | K203335 | 000 |