The following data is part of a premarket notification filed by M.i.s. Implants Technologies Ltd. with the FDA for Bond Bone.
| Device ID | K101014 |
| 510k Number | K101014 |
| Device Name: | BOND BONE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | M.I.S. IMPLANTS TECHNOLOGIES LTD. P.O. BOX 7 Bar Lev Industrial Park, IL 20156 |
| Contact | Iman Khorshid |
| Correspondent | Iman Khorshid M.I.S. IMPLANTS TECHNOLOGIES LTD. P.O. BOX 7 Bar Lev Industrial Park, IL 20156 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290108990089 | K101014 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BOND BONE 77552842 3920202 Live/Registered |
MIS IMPLANTS TECHNOLOGIES LTD. 2008-08-21 |