Dolphix® External Fixation System MR Conditional
Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
CITIEFFE S.r.l
The following data is part of a premarket notification filed by Citieffe S.r.l with the FDA for Dolphix® External Fixation System Mr Conditional.
Pre-market Notification Details
| Device ID | K163323 |
| 510k Number | K163323 |
| Device Name: | Dolphix® External Fixation System MR Conditional |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | CITIEFFE S.r.l Via Armaroli, 21 Calderara Di Reno, IT 400012 |
| Contact | Stefano Pullega |
| Correspondent | Marisa Testa Thelma S.r.l Via Saragat, 5 Imola, IT 40026 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-25 |
| Decision Date | 2017-03-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052990974566 | K163323 | 000 |
| 08056711920320 | K163323 | 000 |
| 08052990970056 | K163323 | 000 |
| 08052990972562 | K163323 | 000 |
| 08052990972548 | K163323 | 000 |
| 08052990971879 | K163323 | 000 |
| 08052990971886 | K163323 | 000 |
| 08052990971916 | K163323 | 000 |
| 08032909627639 | K163323 | 000 |
| 08052990974535 | K163323 | 000 |
| 08051739531237 | K163323 | 000 |
| 08051739531244 | K163323 | 000 |
| 08051739531251 | K163323 | 000 |
| 08052990972654 | K163323 | 000 |
| 08052990972661 | K163323 | 000 |
| 08052990972678 | K163323 | 000 |
| 08052990974542 | K163323 | 000 |
| 08052990974559 | K163323 | 000 |
| 08052990972555 | K163323 | 000 |
Trademark Results [Dolphix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DOLPHIX 85384313 4518123 Live/Registered |
Citieffe S.r.l. 2011-07-29 |
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