| Primary Device ID | G611W1100310 |
| NIH Device Record Key | 46c35245-98b8-43c0-8a4e-f2235fd4f0cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alliant Biotech |
| Version Model Number | W1-1003-1 |
| Catalog Number | W1-1003-1 |
| Company DUNS | 119198202 |
| Company Name | MEDISURGE 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 |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com | |
| Phone | 8883071144 |
| mmorrissey@medisurge.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G611W1100310 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
[G611W1100310]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2024-09-03 |
| G611220811261500 | Symmetric Total Knee Coated Revision Stem Size 26x150 |
| G6112203013550 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x35 |
| G6112203013050 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x30 |
| G6112203011870 | Symmetric Total Knee Ultracongruent Tibial Insert Size 7x18 |
| G6112203002070 | Symmetric Total Knee Standard Tibial Insert Size 7x20 |
| G6112203001870 | Symmetric Total Knee Standard Tibial Insert Size 7x18 |
| G6112203001460 | Symmetric Total Knee Standard Tibial Insert Size 6x14 |
| G61122021260 | Symmetric Total Knee Tibial Tray Size 6 |
| G6112201021050 | Symmetric Total Knee Femoral Component Size 5 Right |
| G6112201020050 | Symmetric Total Knee Femoral Component Size 5 Left |
| G611WF110070 | Cancellous Bone Screw Size 6.5mm x 45mm |
| G61122051024650 | Symmetric Total Knee Metaphyseal Stem Size 24x65 |
| G61122051022600 | Symmetric Total Knee Metaphyseal Stem Size 22x60 |
| G6112203012540 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x25 |
| G6112203011840 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x18 |
| G6112203011440 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x14 |
| G6112203011250 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x12 |
| G6112203001650 | Symmetric Total Knee Standard Tibial Insert Size 5x16 |
| G6112203001450 | Symmetric Total Knee Standard Tibial Insert Size 5x14 |
| G6112201020040 | Symmetric Total Knee Femoral Component Size 4 Left |
| G6112201020030 | Symmetric Total Knee Femoral Component Size 3 Left |
| G6112201021070 | Symmetric Total Knee Femoral Component Size 7 Right |
| G6112201021060 | Symmetric Total Knee Femoral Component Size 6 Right |
| G6112201021040 | Symmetric Total Knee Femoral Component Size 4 Right |
| G6112201021030 | Symmetric Total Knee Femoral Component Size 3 Right |
| G6112201020070 | Symmetric Total Knee Femoral Component Size 7 Left |
| G6112201020060 | Symmetric Total Knee Femoral Component Size 6 Left |
| G61122021270 | Symmetric Total Knee Tibial Tray Size 7 |
| G61122021250 | Symmetric Total Knee Tibial Tray Size 5 |
| G61122021240 | Symmetric Total Knee Tibial Tray Size 4 |
| G61122021230 | Symmetric Total Knee Tibial Tray Size 3 |
| G6112203001470 | Symmetric Total Knee Standard Tibial Insert Size 7x14 |
| G6112203001440 | Symmetric Total Knee Standard Tibial Insert Size 4x14 |
| G6112203001430 | Symmetric Total Knee Standard Tibial Insert Size 3x14 |
| G6112203001270 | Symmetric Total Knee Standard Tibial Insert Size 7x12 |
| G6112203001260 | Symmetric Total Knee Standard Tibial Insert Size 6x12 |
| G6112203001250 | Symmetric Total Knee Standard Size 5x12 |
| G6112203001240 | Symmetric Total Knee Standard Tibial Insert Size 4x12 |
| G6112203001230 | Symmetric Total Knee Standard Tibial Insert Size 3x12 |
| G6112203001070 | Symmetric Total Knee Standard Tibial Insert Size 7x10 |
| G6112203001060 | Symmetric Total Knee Standard Tibial Insert Size 6x10 |
| G6112203001050 | Symmetric Total Knee Standard Tibial Insert Size 5x10 |
| G6112203001040 | Symmetric Total Knee Standard Tibial Insert Size 4x10 |
| G6112203001030 | Symmetric Total Knee Standard Tibial Insert Size 3x10 |
| G6112203011070 | Symmetric Total Knee Ultracongruent Tibial Insert Size 7x10 |
| G6112203011060 | Symmetric Total Knee Ultracongruent Tibial Insert Size 6x10 |
| G6112203011050 | Symmetric Total Knee Ultracongruent Tibial Insert Size 5x10 |
| G6112203011040 | Symmetric Total Knee Ultracongruent Tibial Insert Size 4x10 |
| G6112203011030 | Symmetric Total Knee Ultracongruent Tibial Insert Size 3x10 |
| G6112203002060 | Symmetric Total Knee Standard Tibial Insert Size 6x20 |