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 |