The following data is part of a premarket notification filed by Citieffe S.r.l. with the FDA for Dolphix External Fixation System.
| Device ID | K132363 |
| 510k Number | K132363 |
| Device Name: | DOLPHIX EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | CITIEFFE S.R.L. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin CITIEFFE S.R.L. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2014-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051739531800 | K132363 | 000 |
| 08052990971909 | K132363 | 000 |
| 08032909625307 | K132363 | 000 |
| 08032909625314 | K132363 | 000 |