The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Asnis Micro Cannulated Screw.
| Device ID | K071092 |
| 510k Number | K071092 |
| Device Name: | ASNIS MICRO CANNULATED SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-18 |
| Decision Date | 2007-05-11 |
| Summary: | summary |