The following data is part of a premarket notification filed by Brm Extremities with the FDA for Newprim System.
| Device ID | K191966 |
| 510k Number | K191966 |
| Device Name: | NewPrim System |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | BRM Extremities Via Ciro Menotti 10 Milano, MI 20129 |
| Contact | Andrea De Maglio |
| Correspondent | Margeaux Roger MCRA, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057717550894 | K191966 | 000 |
| 08057717550818 | K191966 | 000 |
| 08057717550825 | K191966 | 000 |
| 08057717550832 | K191966 | 000 |
| 08057717550849 | K191966 | 000 |
| 08057717550856 | K191966 | 000 |
| 08057717550863 | K191966 | 000 |
| 08057717550870 | K191966 | 000 |
| 08057717550887 | K191966 | 000 |
| 08057717550801 | K191966 | 000 |