The following data is part of a premarket notification filed by N.m.b. Medical Applications, Ltd. with the FDA for Piccolo Composite Plate System.
| Device ID | K102597 |
| 510k Number | K102597 |
| Device Name: | PICCOLO COMPOSITE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
| Contact | Hila Wachsler-avrahami |
| Correspondent | Hila Wachsler-avrahami N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Herzeliya, IL 46724 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2011-02-24 |
| Summary: | summary |