The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Hexalon Biodegradable Acl/pcl Screw.
| Device ID | K021280 |
| 510k Number | K021280 |
| Device Name: | INION HEXALON BIODEGRADABLE ACL/PCL SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-22 |
| Decision Date | 2002-07-17 |
| Summary: | summary |