The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Hexalon Biodegradable Acl/pcl Screw.
| Device ID | K071464 |
| 510k Number | K071464 |
| Device Name: | INION HEXALON BIODEGRADABLE ACL/PCL SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224ACL41149 | K071464 | 000 |
| 06438408002496 | K071464 | 000 |
| 06438408002489 | K071464 | 000 |
| 06438408002472 | K071464 | 000 |
| 06438408002465 | K071464 | 000 |
| 06438408002458 | K071464 | 000 |
| 06438408002441 | K071464 | 000 |
| 06438408002434 | K071464 | 000 |
| 06438408002427 | K071464 | 000 |
| 06438408002410 | K071464 | 000 |
| 06438408002403 | K071464 | 000 |
| 06438408002397 | K071464 | 000 |
| 06438408002502 | K071464 | 000 |
| 06438408002519 | K071464 | 000 |
| M224ACL41159 | K071464 | 000 |
| M224ACL41139 | K071464 | 000 |
| M224ACL41129 | K071464 | 000 |
| M224ACL41099 | K071464 | 000 |
| M224ACL41089 | K071464 | 000 |
| M224ACL41079 | K071464 | 000 |
| M224ACL41069 | K071464 | 000 |
| M224ACL41059 | K071464 | 000 |
| M224ACL41049 | K071464 | 000 |
| M224ACL41039 | K071464 | 000 |
| M224ACL41029 | K071464 | 000 |
| M224ACL41019 | K071464 | 000 |
| M224SET40009 | K071464 | 000 |