The following data is part of a premarket notification filed by Exsomed Corporation with the FDA for Innate Cannulated Screw System.
| Device ID | K183603 |
| 510k Number | K183603 |
| Device Name: | INnate Cannulated Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | Exsomed Corporation 7227 N. 16th Street, Suite 245 Phoenix, AZ 85020 |
| Contact | Moira Barton-varty |
| Correspondent | Moira Barton-varty Exsomed Corporation 7227 N. 16th Street, Suite 245 Phoenix, AZ 85020 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B487EXINN9236250 | K183603 | 000 |
| B487EXINN9236550 | K183603 | 000 |
| B487EXINN9236500 | K183603 | 000 |
| B487EXINN9236450 | K183603 | 000 |
| B487EXINN9236400 | K183603 | 000 |
| B487EXINN9236350 | K183603 | 000 |
| B487EXINN9236300 | K183603 | 000 |