The following data is part of a premarket notification filed by N.m.b. Medical Applications, Ltd. with the FDA for Quantum Im Composite Nailing System (quantum Nailing System).
| Device ID | K100497 |
| 510k Number | K100497 |
| Device Name: | QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-22 |
| Decision Date | 2010-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110202088 | K100497 | 000 |
| 07290109331898 | K100497 | 000 |