The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Miot Plating System.
| Device ID | K051945 |
| 510k Number | K051945 |
| Device Name: | MIOT PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOFIX SRL 632 DUNDEE DRIVE Wilmington, NC 28405 |
| Contact | Candace F Cederman |
| Correspondent | Candace F Cederman ORTHOFIX SRL 632 DUNDEE DRIVE Wilmington, NC 28405 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18032937161034 | K051945 | 000 |
| 18032937160129 | K051945 | 000 |
| 18032937160112 | K051945 | 000 |
| 18032937160105 | K051945 | 000 |
| 18032937160099 | K051945 | 000 |
| 18032937160082 | K051945 | 000 |
| 18032937160075 | K051945 | 000 |
| 18032937160068 | K051945 | 000 |
| 18032937160051 | K051945 | 000 |
| 18032937160044 | K051945 | 000 |
| 18032937160037 | K051945 | 000 |
| 18032937160020 | K051945 | 000 |
| 18032937160013 | K051945 | 000 |
| 18032937160136 | K051945 | 000 |
| 18032937160143 | K051945 | 000 |
| 18032937161027 | K051945 | 000 |
| 18032937161010 | K051945 | 000 |
| 18032937161003 | K051945 | 000 |
| 18032937160990 | K051945 | 000 |
| 18032937160228 | K051945 | 000 |
| 18032937160211 | K051945 | 000 |
| 18032937160204 | K051945 | 000 |
| 18032937160198 | K051945 | 000 |
| 18032937160181 | K051945 | 000 |
| 18032937160174 | K051945 | 000 |
| 18032937160167 | K051945 | 000 |
| 18032937160150 | K051945 | 000 |
| 18032568868685 | K051945 | 000 |