The following data is part of a premarket notification filed by Baxano, Inc. with the FDA for Neuro Check Device With Io-flex Wire.
| Device ID | K113533 |
| 510k Number | K113533 |
| Device Name: | NEURO CHECK DEVICE WITH IO-FLEX WIRE |
| Classification | Rongeur, Manual |
| Applicant | BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Contact | Edward Sinclair |
| Correspondent | Edward Sinclair BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-30 |
| Decision Date | 2012-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840916103897 | K113533 | 000 |
| 00840916103774 | K113533 | 000 |
| 00840916103781 | K113533 | 000 |
| 00840916103798 | K113533 | 000 |
| 00840916103811 | K113533 | 000 |
| 00840916103828 | K113533 | 000 |
| 00840916103835 | K113533 | 000 |
| 00840916103842 | K113533 | 000 |
| 00840916103859 | K113533 | 000 |
| 00840916103880 | K113533 | 000 |
| 00840916103767 | K113533 | 000 |