Inion S-1™ SPN-5202
GUDID M224SPN52029
4.5 x 16 mm screw (4 x)
Inion Oy
Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable Spinal bone screw, bioabsorbable| Primary Device ID | M224SPN52029 |
| NIH Device Record Key | b41b75d3-4819-4af5-ba73-16ab4fc8ff7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inion S-1™ |
| Version Model Number | 1 |
| Catalog Number | SPN-5202 |
| Company DUNS | 367994657 |
| Company Name | Inion Oy |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M224SPN52029 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051821
FDA Product Code
| OJB | Resorbable spinal intervertebral body fixation orthosis - plate |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2018-11-22 |
On-Brand Devices [Inion S-1™]
| 06438408006944 | 5.0 x 16 mm screw |
| 06438408006937 | 5.0 x 14 mm screw |
| 06438408006920 | 5.0 x 12 mm screw |
| 06438408006913 | 4.5 x 16 mm screw |
| 06438408006906 | 4.5 x 14 mm screw |
| 06438408006890 | 4.5 x 12 mm screw |
| M224SPN52129 | 4.5 x 16 mm screw |
| M224SPN52119 | 4.5 x 14 mm screw |
| M224SPN52109 | 4.5 x 12 mm screw |
| M224SPN52059 | 5.0 x 16 mm screw |
| M224SPN52049 | 5.0 x 14 mm screw |
| M224SPN52039 | 5.0 x 12 mm screw |
| M224SPN52029 | 4.5 x 16 mm screw (4 x) |
| M224SPN52019 | 4.5 x 14 mm screw (4 x) |
| M224SPN52009 | 4.5 x 12 mm screw (4 x) |
| M224SPN50219 | Plate, 48 x 19 x 2.0 mm |
| M224SPN50209 | Plate, 45 x 19 x 2.0 mm |
| 06438408006869 | Plate, 42 x 19 x 2.0 mm |
| 06438408006852 | Plate, 39 x 19 x 2.0 mm |
| 06438408006845 | Plate, 36 x 19 x 2.0 mm |
| 06438408006838 | Plate, 33 x 19 x 2.0 mm |
| 06438408006821 | Plate, 31 x 19 x 2.0 mm |
| 06438408006814 | Plate, 29 x 19 x 2.0 mm |
| 06438408006807 | Plate, 27 x 19 x 2.0 mm |
| M224SPN50129 | Plate, 25 x 19 x 2.0 mm |
| M224SPN50119 | Plate, 23 x 19 x 2.0 mm |
| M224SPN50109 | Plate, 21 x 19 x 2.0 mm |
| M224SPN50079 | Plate, 31 x 19 x 0.8 mm |
| M224SPN50069 | Plate, 29 x 19 x 0.8 mm |
| M224SPN50059 | Plate, 27 x 19 x 0.8 mm |
| M224SPN50049 | Plate, 25 x 19 x 0.8 mm |
| M224SPN50039 | Plate, 31 x 19 x 2.0 mm |
| M224SPN50029 | Plate, 29 x 19 x 2.0 mm |
| M224SPN50019 | Plate, 27 x 19 x 2.0 mm |
| M224SPN50009 | Plate, 25 x 19 x 2.0 mm |
| M224SPN52259 | 5.0 x 16 mm screw |
| M224SPN52249 | 5.0 x 14 mm screw |
| M224SPN52239 | 5.0 x 12 mm screw |
| M224SPN52229 | 4.5 x 16 mm screw |
| M224SPN52219 | 4.5 x 14 mm screw |
| M224SPN52209 | 4.5 x 12 mm screw |
| M224SPN50199 | Plate, 42 x 19 x 2.0 mm |
| M224SPN50189 | Plate, 39 x 19 x 2.0 mm |
| M224SPN50179 | Plate, 36 x 19 x 2.0 mm |
| M224SPN50169 | Plate, 33 x 19 x 2.0 mm |
| M224SPN50159 | Plate, 31 x 19 x 2.0 mm |
| M224SPN50149 | Plate, 29 x 19 x 2.0 mm |
| M224SPN50139 | Plate, 27 x 19 x 2.0 mm |
| 06438408012303 | 4.5 x 16 mm screw |
| 06438408012297 | 4.5 x 14 mm screw |
Trademark Results [Inion S-1]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INION S-1 79023407 3275402 Dead/Cancelled |
INION OY 2006-03-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.