The following data is part of a premarket notification filed by Citieffe S.r.l. with the FDA for Pl8 Wrist Reconstruction Plate.
| Device ID | K180150 |
| 510k Number | K180150 |
| Device Name: | PL8 Wrist Reconstruction Plate |
| Classification | Plate, Fixation, Bone |
| Applicant | CITIEFFE S.r.l. Via Armaroli, 21 Calderara Di Reno, IT 40012 |
| Contact | Stefano Pullega |
| Correspondent | Stefano Pullega CITIEFFE S.r.l. Via Armaroli, 21 Calderara Di Reno, IT 40012 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-19 |
| Decision Date | 2018-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051739534771 | K180150 | 000 |
| 08052990970483 | K180150 | 000 |
| 08052990970476 | K180150 | 000 |
| 08052990970469 | K180150 | 000 |
| 08052990970452 | K180150 | 000 |
| 08052990970445 | K180150 | 000 |
| 08052990970438 | K180150 | 000 |
| 08052990970421 | K180150 | 000 |
| 08052990970414 | K180150 | 000 |
| 08052990970407 | K180150 | 000 |
| 08052990970391 | K180150 | 000 |
| 08052990970384 | K180150 | 000 |
| 08052990970377 | K180150 | 000 |
| 08052990970360 | K180150 | 000 |
| 08052990970353 | K180150 | 000 |
| 08052990970346 | K180150 | 000 |
| 08052990970339 | K180150 | 000 |
| 08052990970322 | K180150 | 000 |
| 08052990970490 | K180150 | 000 |
| 08052990970506 | K180150 | 000 |
| 08052990970513 | K180150 | 000 |
| 08051739534764 | K180150 | 000 |
| 08051739534757 | K180150 | 000 |
| 08052990970636 | K180150 | 000 |
| 08052990972692 | K180150 | 000 |
| 08052990971282 | K180150 | 000 |
| 08052990970308 | K180150 | 000 |
| 08052990970292 | K180150 | 000 |
| 08052990970285 | K180150 | 000 |
| 08052990970278 | K180150 | 000 |
| 08052990970261 | K180150 | 000 |
| 08052990970254 | K180150 | 000 |
| 08052990970247 | K180150 | 000 |
| 08052990970230 | K180150 | 000 |
| 08052990970575 | K180150 | 000 |
| 08052990970544 | K180150 | 000 |
| 08052990970537 | K180150 | 000 |
| 08052990970520 | K180150 | 000 |
| 08052990970315 | K180150 | 000 |