The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd with the FDA for Piezo Bone Surgery.
| Device ID | K111290 |
| 510k Number | K111290 |
| Device Name: | PIEZO BONE SURGERY |
| Classification | Drill, Bone, Powered |
| Applicant | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD 7325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD 7325 JOYCE WAY Echo, OR 97826 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2011-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944843605654 | K111290 | 000 |
| 06944843601854 | K111290 | 000 |
| 06944843604442 | K111290 | 000 |
| D966WPUI3A0 | K111290 | 000 |
| D966WPUI4A0 | K111290 | 000 |
| D966WPUI5A0 | K111290 | 000 |
| D966WPUI6A0 | K111290 | 000 |
| D966WPUI7A0 | K111290 | 000 |
| D966WPUP2A0 | K111290 | 000 |
| D966WPUP3A0 | K111290 | 000 |
| D966WPUP4A0 | K111290 | 000 |
| D966WPUP6A0 | K111290 | 000 |
| D966WPUP7A0 | K111290 | 000 |
| D966B10 | K111290 | 000 |
| 06944843601717 | K111290 | 000 |
| 06944843604688 | K111290 | 000 |
| 06944843605807 | K111290 | 000 |
| 06944843604954 | K111290 | 000 |
| 06944843604961 | K111290 | 000 |
| 06944843604978 | K111290 | 000 |
| 06944843604985 | K111290 | 000 |
| 06944843604992 | K111290 | 000 |
| 06944843605098 | K111290 | 000 |
| 06944843605104 | K111290 | 000 |
| 06944843605111 | K111290 | 000 |
| 06944843605142 | K111290 | 000 |
| 06944843605159 | K111290 | 000 |
| 06944843611440 | K111290 | 000 |
| 06944843611457 | K111290 | 000 |
| 06944843604923 | K111290 | 000 |
| D966BPS1LED0 | K111290 | 000 |
| D966HBPS1LED0 | K111290 | 000 |
| 06944843600710 | K111290 | 000 |
| 06944843600727 | K111290 | 000 |
| 06944843600734 | K111290 | 000 |
| 06944843600741 | K111290 | 000 |
| 06944843600758 | K111290 | 000 |
| 06944843605005 | K111290 | 000 |
| 06944843605029 | K111290 | 000 |
| 06944843605043 | K111290 | 000 |
| 06944843606163 | K111290 | 000 |
| 06944843606187 | K111290 | 000 |
| 06944843606880 | K111290 | 000 |
| 06944843606897 | K111290 | 000 |
| 06944843608617 | K111290 | 000 |
| 06944843600321 | K111290 | 000 |
| 06944843600260 | K111290 | 000 |
| 06944843600253 | K111290 | 000 |
| D769NRP10 | K111290 | 000 |
| 06944843604220 | K111290 | 000 |
| 06944843604237 | K111290 | 000 |
| 06944843604244 | K111290 | 000 |
| 06944843604251 | K111290 | 000 |
| 06944843603636 | K111290 | 000 |
| 06944843603643 | K111290 | 000 |
| 06944843603971 | K111290 | 000 |
| 06944843603995 | K111290 | 000 |
| 06944843600970 | K111290 | 000 |
| 06944843600222 | K111290 | 000 |
| 06944843600239 | K111290 | 000 |
| 06944843600246 | K111290 | 000 |
| 06944843611020 | K111290 | 000 |