The following data is part of a premarket notification filed by N.m.b. Medical Applications, Ltd. with the FDA for Piccolo Composite Nailing System.
| Device ID | K102369 |
| 510k Number | K102369 |
| Device Name: | PICCOLO COMPOSITE NAILING SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Harzeliya, IL 46724 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Harzeliya, IL 46724 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2011-01-31 |
| Summary: | summary |