The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing, Llc with the FDA for Surgical Drills.
| Device ID | K200265 |
| 510k Number | K200265 |
| Device Name: | Surgical Drills |
| Classification | Drill, Bone, Powered |
| Applicant | Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Contact | Reina Choi |
| Correspondent | Reina Choi Implant Direct Sybron Manufacturing, LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-03 |
| Decision Date | 2020-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307124931 | K200265 | 000 |
| 10841307124801 | K200265 | 000 |
| 10841307124795 | K200265 | 000 |
| 10841307124788 | K200265 | 000 |
| 10841307124771 | K200265 | 000 |
| 10841307124764 | K200265 | 000 |
| 10841307124757 | K200265 | 000 |
| 10841307124740 | K200265 | 000 |
| 10841307124733 | K200265 | 000 |
| 10841307124726 | K200265 | 000 |
| 10841307124818 | K200265 | 000 |
| 10841307124825 | K200265 | 000 |
| 10841307124832 | K200265 | 000 |
| 10841307124924 | K200265 | 000 |
| 10841307124917 | K200265 | 000 |
| 10841307124900 | K200265 | 000 |
| 10841307124894 | K200265 | 000 |
| 10841307124887 | K200265 | 000 |
| 10841307124870 | K200265 | 000 |
| 10841307124863 | K200265 | 000 |
| 10841307124856 | K200265 | 000 |
| 10841307124849 | K200265 | 000 |
| 10841307124719 | K200265 | 000 |