The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Biorestore.
| Device ID | K070998 |
| 510k Number | K070998 |
| Device Name: | INION BIORESTORE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen INION OY LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-09 |
| Decision Date | 2007-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224BRS54319 | K070998 | 000 |
| 06438408009068 | K070998 | 000 |
| 06438408009600 | K070998 | 000 |
| 06438408008955 | K070998 | 000 |
| 06438408008962 | K070998 | 000 |
| 06438408008979 | K070998 | 000 |
| 06438408008993 | K070998 | 000 |
| 06438408009006 | K070998 | 000 |
| 06438408009013 | K070998 | 000 |
| 06438408009242 | K070998 | 000 |
| 06438408009259 | K070998 | 000 |
| 06438408009266 | K070998 | 000 |
| 06438408009273 | K070998 | 000 |
| 06438408009617 | K070998 | 000 |
| M224BRS16119 | K070998 | 000 |
| M224BRS16209 | K070998 | 000 |
| M224BRS54139 | K070998 | 000 |
| M224BRS54309 | K070998 | 000 |
| 06438408008986 | K070998 | 000 |