The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Asnis Iii Cannulated Screw System.
| Device ID | K000080 |
| 510k Number | K000080 |
| Device Name: | ASNIS III CANNULATED SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Mary-catherine Dillon |
| Correspondent | Mary-catherine Dillon HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-11 |
| Decision Date | 2000-04-03 |