| Primary Device ID | 00811714033617 |
| NIH Device Record Key | 80853108-a479-4fe9-8495-9020694fcd11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spirit PEEK Screw |
| Version Model Number | 900000-0828 |
| Catalog Number | 900000-0828 |
| Company DUNS | 002745858 |
| Company Name | RESPONSIVE ORTHOPEDICS LLC |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00811714033617 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-06 |
| Device Publish Date | 2021-04-28 |
| 00811714034164 | 900000-1135 |
| 00811714034096 | 900000-1128 |
| 00811714034041 | 900000-1123 |
| 00811714034003 | 900000-1035 |
| 00811714033938 | 900000-1028 |
| 00811714033884 | 900000-1023 |
| 00811714033846 | 900000-0935 |
| 00811714033778 | 900000-0928 |
| 00811714033723 | 900000-0923 |
| 00811714033686 | 900000-0835 |
| 00811714033617 | 900000-0828 |
| 00811714033563 | 900000-0823 |
| 00811714033525 | 900000-0735 |
| 00811714033457 | 900000-0728 |
| 00811714033402 | 900000-0723 |