| Primary Device ID | 00811714036168 |
| NIH Device Record Key | 2e4c0301-d10f-488c-856d-2a09ba5e3861 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Superhawk |
| Version Model Number | 285927 |
| Catalog Number | 285927 |
| Company DUNS | 002745858 |
| Company Name | RESPONSIVE ORTHOPEDICS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00811714036168 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
[00811714036168]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-22 |
| Device Publish Date | 2025-05-14 |
| 00811714035321 | Superhawk Suture Anchor |
| 00811714035314 | Superhawk Suture Anchor |
| 00811714035468 | Superhawk Broach 3.75 |
| 00811714035451 | Superhawk Drill 3.75 Cannulated |
| 00811714035444 | Superhawk Drill 3.75 |
| 00811714035437 | Superhawk Drill Guide Circle |
| 00811714035079 | Superhawk Broach 4.75 |
| 00811714034980 | Superhawk Drill 4.75 |
| 00811714034959 | Superhawk Guide Wire Short |
| 00811714034935 | Superhawk Drill Guide Insert |
| 00811714034904 | Superhawk Drill 4.75 Cannulated |
| 00811714035086 | Superhawk Instrument Set |
| 00811714035819 | Superhawk Surgical Drill 3.5mm |
| 00811714035840 | Superhawk 3.0mm Drill |
| 00811714035833 | Superhawk Circle Drill Guide |
| 00811714035499 | Superhawk Guide Wire Short |
| 00811714035918 | Superhawk Broach 4.75 - Packaged |
| 00811714035901 | Superhawk Broach 3.75 - Packaged |
| 00811714036274 | Superhawk Drill Guide Circle |
| 00811714036267 | Superhawk Broach 4.75mm |
| 00811714036250 | Superhawk Broach 3.75mm |
| 00811714036243 | Superhawk Drill Guide |
| 00811714036236 | Superhawk Guidewire 150mm Length |
| 00811714036229 | Superhawk Cannulated Drill 3.5mm |
| 00811714036212 | Superhawk Drill 3.0mm |
| 00811714036205 | Superhawk Cannulated Drill 3.0mm |
| 00811714036199 | Superhawk Drill 3.5mm |
| 00811714036168 | Superhawk Instrument Tray |
| 00811714036151 | Superhawk 3.75mm End Suture Anchor |
| 00811714036144 | Superhawk 3.75mm/4.75mm Suture Anchors |