The following data is part of a premarket notification filed by Citieffe S.r.l with the FDA for St.a.r. 90 F4 External Fixation Screws With Hydroxyapatite.
| Device ID | K150661 |
| 510k Number | K150661 |
| Device Name: | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite |
| Classification | Pin, Fixation, Threaded |
| Applicant | CITIEFFE S.r.l Via Armaroli 21 Calderara Di Reno, IT 400012 |
| Contact | Stefano Pullega |
| Correspondent | Marisa Testa Thema S.r.l. Via Saragat 5 Imola, IT 40026 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-13 |
| Decision Date | 2015-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056711920061 | K150661 | 000 |
| B56211701156180S00 | K150661 | 000 |
| B56211701156150S00 | K150661 | 000 |
| 08056711928517 | K150661 | 000 |
| 08056711928500 | K150661 | 000 |
| 08056711928494 | K150661 | 000 |
| 08056711928487 | K150661 | 000 |
| 08052990978090 | K150661 | 000 |
| 08052990978083 | K150661 | 000 |
| 08032909624706 | K150661 | 000 |
| B56211701256150S00 | K150661 | 000 |
| B56211701360120S00 | K150661 | 000 |
| B56211701360148S00 | K150661 | 000 |
| 08056711920054 | K150661 | 000 |
| 08056711920047 | K150661 | 000 |
| 08052990971398 | K150661 | 000 |
| 08052990971381 | K150661 | 000 |
| 08052990971374 | K150661 | 000 |
| B56211701360198S00 | K150661 | 000 |
| B56211701360180S00 | K150661 | 000 |
| B56211701360178S00 | K150661 | 000 |
| B56211701360150S00 | K150661 | 000 |
| 08032909624690 | K150661 | 000 |