HammerTech CD-HT-1000-S
GUDID 00840124508170
HT Awl (Single)
FUSION ORTHOPEDICS, LLC
Bone awl, reusable| Primary Device ID | 00840124508170 |
| NIH Device Record Key | 7f62e3e9-328c-448b-8ccf-4d9dda3ccc39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HammerTech |
| Version Model Number | CD-HT-1000-S |
| Catalog Number | CD-HT-1000-S |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| 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 | true |
| 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 |
|---|---|
| GS1 | 00840124508170 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182684
FDA Product Code
| HWJ | Awl |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
[00840124508170]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-26 |
| Device Publish Date | 2023-06-16 |
On-Brand Devices [HammerTech]
| 00852164007032 | Large PIP Implant |
| 00852164007025 | Medium PIP Implant |
| 00852164007018 | Small PIP Implant |
| 00852164007001 | Extra Small PIP Implant |
| 00852164007407 | PEEK Implant Large |
| 00852164007391 | PEEK Implant Medium |
| 00852164007384 | PEEK Implant Small |
| 00852164007377 | PEEK Implant Extra Small |
| 00852164007360 | PEEK Implant Petite |
| 00852164007339 | Ti Implant 10° Angled Large |
| 00852164007322 | Ti Implant 10° Angled Medium |
| 00852164007315 | Ti Implant 10° Angled Small |
| 00852164007308 | Ti Implant 10° Angled Extra Small |
| 00852164007292 | Ti Implant 10° Angled Petite |
| 00852164007278 | Ti Implant Medium |
| 00852164007261 | Ti Implant Small |
| 00852164007254 | Ti Implant Extra Small |
| 00852164007247 | Ti Implant Petite |
| 00819034027460 | HT Ti Angled Driver Petite |
| 00819034027453 | HT Ti Standard Driver Medium |
| 00819034027446 | HT Ti Standard Driver Large |
| 00819034027439 | HT Ti Standard Driver Small |
| 00819034027248 | HT PEEK Removal Tool |
| 00819034027231 | HT PEEK Sizer Wheel |
| 00819034027187 | HT PEEK Calibrated Drill Large |
| 00819034027170 | HT PEEK Calibrated Drill Medium |
| 00819034027163 | HT PEEK Calibrated Drill Small |
| 00819034027156 | HT PEEK Calibrated Drill Extra Small |
| 00819034027149 | HT PEEK Calibrated Drill Petite |
| 00819034027132 | HT PEEK Driver Large |
| 00819034027125 | HT PEEK Driver Medium |
| 00819034027118 | HT PEEK Driver Small |
| 00819034027101 | HT PEEK Driver Extra Small |
| 00819034027095 | HT PEEK Driver Petite |
| 00819034024872 | HT Ti Standard Driver Extra Small |
| 00819034024841 | HT Ti Standard Driver Petite |
| 00852164007988 | Cup and Cone Reamer Implant System 12mm |
| 00852164007971 | Cup and Cone Reamer Implant System 10mm |
| 00852164007964 | Cup and Cone Reamer Implant System 8mm |
| 00852164007957 | Removal Tool PEEK |
| 00852164007940 | HT Ti Sizer Wheel Titanium |
| 00852164007933 | HT Ti Sizer Wheel Titanium |
| 00852164007926 | HT Awl (Single) |
| 00852164007919 | PEEK Implant Instrument Kit Large |
| 00852164007902 | HT Sizer Wheel PEEK |
| 00852164007896 | PEEK Implant Instrument Kit Medium |
| 00852164007889 | PEEK Implant Instrument Kit Small |
| 00852164007872 | PEEK Implant Instrument Kit Extra Small |
| 00852164007865 | PEEK Implant Instrument Kit Petite |
| 00852164007858 | Large PEEK Implant (Single) |
Trademark Results [HammerTech]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAMMERTECH 90715358 not registered Live/Pending |
Hammer Technologies Pty Ltd 2021-05-17 |
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