The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Cps 1.5/2.0/2.5 Bioabsorbable Fixation System.
| Device ID | K010352 |
| 510k Number | K010352 |
| Device Name: | CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | INION LTD. 3 SORINKATU Tampere, FI 33100 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. 3 SORINKATU Tampere, FI 33100 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-06 |
| Decision Date | 2001-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408001123 | K010352 | 000 |
| M224PLT10149 | K010352 | 000 |
| M224PLT10169 | K010352 | 000 |
| M224PLT10179 | K010352 | 000 |
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| M224PLT10229 | K010352 | 000 |
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| M224PLT10259 | K010352 | 000 |
| M224PLT10139 | K010352 | 000 |
| M224PLT10129 | K010352 | 000 |
| M224PLT10119 | K010352 | 000 |
| 06438408001130 | K010352 | 000 |
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