The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Otps Biodegradable Distal Radius Plate.
| Device ID | K052624 |
| 510k Number | K052624 |
| Device Name: | INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-23 |
| Decision Date | 2005-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224FRF10619 | K052624 | 000 |
| M224FRF10609 | K052624 | 000 |
| 06438408005619 | K052624 | 000 |
| 06438408005602 | K052624 | 000 |