| Primary Device ID | 00840118113199 |
| NIH Device Record Key | 176ea0a1-a613-4cdf-a002-2b3fc3687abe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opening Wedge Plate, 5.5mm |
| Version Model Number | FOW 055 |
| Company DUNS | 078790947 |
| Company Name | FLOWER ORTHOPEDICS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00840118113199 [Primary] |
| HRS | Plate, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-30 |
| 00840118125802 - Flower Orthopedics | 2025-04-21 Trephine Cannula |
| 00840118124096 - Flower Orthopedics | 2025-02-06 OsteoCoil Nitinol Compression System- 4.5mm x 35mm |
| 00840118124539 - Flower Orthopedics | 2025-02-06 OsteoCoil Nitinol Compression System- 6.5mm x 105mm |
| 00840118124690 - Flower Orthopedics | 2025-02-06 OsteoCoil Nitinol Compression System- 7.3mm x 60mm |
| 00840118124089 - Flower Orthopedics | 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 30mm |
| 00840118124126 - Flower Orthopedics | 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 50mm |
| 00840118124140 - Flower Orthopedics | 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 60mm |
| 00840118124188 - Flower Orthopedics | 2025-02-05 OsteoCoil Nitinol Compression System- 4.5mm x 80mm |