The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Aperfix Interference Screw 7-12 Mm X 20 Mm; 7-12 Mm X 25 Mm; 7-12 Mm X 30 Mm.
| Device ID | K073426 |
| 510k Number | K073426 |
| Device Name: | APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM |
| Classification | Screw, Fixation, Bone |
| Applicant | CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Kereshmeh Shahriari CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-05 |
| Decision Date | 2008-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868269608 | K073426 | 000 |
| 00887868269479 | K073426 | 000 |
| 00887868269486 | K073426 | 000 |
| 00887868269493 | K073426 | 000 |
| 00887868269530 | K073426 | 000 |
| 00887868269547 | K073426 | 000 |
| 00887868269554 | K073426 | 000 |
| 00887868269561 | K073426 | 000 |
| 00887868269578 | K073426 | 000 |
| 00887868269585 | K073426 | 000 |
| 00887868269592 | K073426 | 000 |
| 00887868269462 | K073426 | 000 |