Hammerdesis™ Interphalangeal Fusion System
GUDID G079HMR2030
Caddy
Intelivation, LLC
Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | G079HMR2030 |
| NIH Device Record Key | 1f4970d0-9b32-4932-88a6-d277f8acbc06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hammerdesis™ Interphalangeal Fusion System |
| Version Model Number | HMR-203 |
| 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G079HMR2030 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231147
FDA Product Code
| FSM | Tray, Surgical, Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
[G079HMR2030]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.