The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion S-1 Biodegradable Anterior Cervical Fusion System.
| Device ID | K051821 |
| 510k Number | K051821 |
| Device Name: | INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM |
| Classification | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | OJB |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224SPN52129 | K051821 | 000 |
| 06438408012297 | K051821 | 000 |
| 06438408012280 | K051821 | 000 |
| 06438408012273 | K051821 | 000 |
| 06438408012266 | K051821 | 000 |
| 06438408012259 | K051821 | 000 |
| 06438408012242 | K051821 | 000 |
| 06438408012235 | K051821 | 000 |
| 06438408012228 | K051821 | 000 |
| 06438408012211 | K051821 | 000 |
| 06438408012204 | K051821 | 000 |
| 06438408012198 | K051821 | 000 |
| 06438408012181 | K051821 | 000 |
| 06438408012174 | K051821 | 000 |
| 06438408012167 | K051821 | 000 |
| 06438408012150 | K051821 | 000 |
| 06438408012303 | K051821 | 000 |
| M224SPN50009 | K051821 | 000 |
| M224SPN52119 | K051821 | 000 |
| M224SPN52109 | K051821 | 000 |
| M224SPN52059 | K051821 | 000 |
| M224SPN52049 | K051821 | 000 |
| M224SPN52039 | K051821 | 000 |
| M224SPN52029 | K051821 | 000 |
| M224SPN52019 | K051821 | 000 |
| M224SPN52009 | K051821 | 000 |
| M224SPN50079 | K051821 | 000 |
| M224SPN50069 | K051821 | 000 |
| M224SPN50059 | K051821 | 000 |
| M224SPN50049 | K051821 | 000 |
| M224SPN50039 | K051821 | 000 |
| M224SPN50029 | K051821 | 000 |
| M224SPN50019 | K051821 | 000 |
| 06438408012143 | K051821 | 000 |