The following data is part of a premarket notification filed by K2m Inc. with the FDA for Cannulated Power Driver Attachment.
| Device ID | K202528 |
| 510k Number | K202528 |
| Device Name: | Cannulated Power Driver Attachment |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | K2M Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Megan Callanan |
| Correspondent | Megan Callanan K2M Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-01 |
| Decision Date | 2020-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857104099 | K202528 | 000 |
| 07613327598940 | K202528 | 000 |