| Primary Device ID | 00811714035895 |
| NIH Device Record Key | 844f109f-5a05-45f4-a061-48f5aac835a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shadow Knotless All-Suture Anchors |
| Version Model Number | 920000-0003 |
| Catalog Number | 920000-0003 |
| 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 | 00811714035895 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-14 |
| Device Publish Date | 2023-11-06 |
| 00811714036144 - Superhawk | 2025-05-22 Superhawk 3.75mm/4.75mm Suture Anchors |
| 00811714036151 - Superhawk | 2025-05-22 Superhawk 3.75mm End Suture Anchor |
| 00811714036168 - Superhawk | 2025-05-22 Superhawk Instrument Tray |
| 00811714036199 - Superhawk | 2025-05-22 Superhawk Drill 3.5mm |
| 00811714036205 - Superhawk | 2025-05-22 Superhawk Cannulated Drill 3.0mm |
| 00811714036212 - Superhawk | 2025-05-22 Superhawk Drill 3.0mm |
| 00811714036229 - Superhawk | 2025-05-22 Superhawk Cannulated Drill 3.5mm |
| 00811714036236 - Superhawk | 2025-05-22 Superhawk Guidewire 150mm Length |