The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Dental Bone Cutting Instruments.
| Device ID | K150796 |
| 510k Number | K150796 |
| Device Name: | Dental Bone Cutting Instruments |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | SYNTHES (USA) PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES (USA) PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-26 |
| Decision Date | 2015-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9803112430 | K150796 | 000 |
| H9803108050 | K150796 | 000 |
| H980310800 | K150796 | 000 |
| H980SD3112480 | K150796 | 000 |
| H980SD3112470 | K150796 | 000 |
| H980SD3112460 | K150796 | 000 |
| H980SD3112450 | K150796 | 000 |
| H980SD3112440 | K150796 | 000 |
| H980SD3112430 | K150796 | 000 |
| H679311190 | K150796 | 000 |
| H980310810 | K150796 | 000 |
| H9803108110 | K150796 | 000 |
| H9803108830 | K150796 | 000 |
| H9803112420 | K150796 | 000 |
| H9803112410 | K150796 | 000 |
| H980311240 | K150796 | 000 |
| H980311230 | K150796 | 000 |
| H9803112110 | K150796 | 000 |
| H98031121980 | K150796 | 000 |
| H9803112090 | K150796 | 000 |
| H9803112040 | K150796 | 000 |
| H9803111200 | K150796 | 000 |
| H679311150 | K150796 | 000 |