Hammerdesis™ Interphalangeal Fusion System
GUDID G079HMR4565D0
Intelivation, LLC
Interphalangeal joint arthrodesis implant| Primary Device ID | G079HMR4565D0 |
| NIH Device Record Key | fcec6dd2-b801-4814-b1c2-c4a23986d91e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hammerdesis™ Interphalangeal Fusion System |
| Version Model Number | HMR-4565D |
| Company DUNS | 037368183 |
| Company Name | Intelivation, 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G079HMR4565D0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231147
FDA Product Code
| HTY | Pin, Fixation, Smooth |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
[G079HMR4565D0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-04-09 |
| Device Publish Date | 2024-04-01 |
On-Brand Devices [Hammerdesis™ Interphalangeal Fusion System]
| G079HMR4565D0 | HMR-4565D |
| G079HMR45650 | Counter Rotation Ring, Large |
| G079HMR2030 | Caddy |
| G079HMR116020 | K-Wire Tube |
| G079HMR116010 | 1.1mm K-Wire |
| G079HMR1084565P0 | Peg Reamer, Large |
| G079HMR1084565H0 | Hole Reamer, Large |
| G079HMR1080406P0 | Peg Reamer, Small |
| G079HMR1080406H0 | Hole Reamer, Small |
| G079HMR102S0 | Inserter, Forceps |
| G079HMR0406D0 | Recovery Dowel, Small |
| G079HMR04060 | Counter Rotation Ring, Small |
Trademark Results [Hammerdesis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAMMERDESIS 97531376 not registered Live/Pending |
Intelivation Technologies, LLC 2022-08-02 |
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