| Primary Device ID | 03701037300398 |
| NIH Device Record Key | 0a28aed6-f749-4805-8b49-f3c510e3dace |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Humelock II Cemented Shoulder System |
| Version Model Number | 106-4115 |
| Catalog Number | 106-4115 |
| Company DUNS | 263076196 |
| Company Name | FX SOLUTIONS |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Outer Diameter | 41 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037300398 [Primary] |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-07 |
| Device Publish Date | 2016-06-09 |
| 03701037307199 | CANNULATED HEX 3.5 SCREW DRIVER |
| 03701037307182 | HUMELOCK AIMING GUIDE SCREW |
| 03701037307168 | TRAUMA IMPACTOR |
| 03701037307137 | OSTEOTOME |
| 03701037307106 | HUMELOCK HEIGHT GAUGE AXIS POINT |
| 03701037306864 | HUMELOCK ANCHORING PLATE IMPACTOR HANDLE |
| 03701037306857 | HUMELOCK HEAD IMPACTOR BIT |
| 03701037306840 | HUMELOCK HEAD IMPACTOR HANDLE |
| 03701037306833 | STABILIZATION POST FORCEPS |
| 03701037306826 | STABILIZATION POST |
| 03701037306819 | GLENOID REMOVAL |
| 03701037306796 | DRILL BIT Ø4.5mm L150mm/ AO |
| 03701037306765 | GLENOID RESURFACING REAMER Ø39 mm/30 /AO |
| 03701037306758 | GLENOID RESURFACING REAMER Ø35 mm/30 /AO |
| 03701037306741 | GLENOID RESURFACING REAMER Ø31 mm/30 /AO |
| 03701037306734 | GLENOID RESURFACING REAMER Ø27 mm/30 /AO |
| 03701037306536 | HEX 3,5mm KEY |
| 03701037306529 | SCREW / RASP HANDLE |
| 03701037306512 | RASP HANDLE |
| 03701037306468 | STABILIZATION POST Ø7.5 |
| 03701037306451 | HUMELOCK STAINLESS STEEL RULER L.150 |
| 03701037306444 | HUMELOCK CORTICAL SCREW GAUGE |
| 03701037306383 | STOP DRILL BIT Ø7.5mm L.150 |
| 03701037305805 | HEAD IMPACTOR |
| 03701037305799 | TAPER IMPACTOR |
| 03701037305782 | Ø34 IMPACTOR BIT |
| 03701037305775 | PUNCHER Ø38mm |
| 03701037305768 | PUNCHER Ø34mm |
| 03701037305751 | PUNCHER Ø30mm |
| 03701037305744 | K-WIRE CENTER GUIDE Ø50 mm |
| 03701037305737 | K-WIRE CENTER GUIDE Ø46 mm |
| 03701037305720 | K-WIRE CENTER GUIDE Ø43 mm |
| 03701037305713 | K-WIRE CENTER GUIDE Ø39 mM |
| 03701037305706 | EASYTECH SUPERIOR LATERAL CUTTING GUIDE |
| 03701037305690 | EASYTECH LEFT DELTO PECTORAL CUTTING GUIDE |
| 03701037305683 | EASYTECH RIGHT DELTO PECTORAL CUTTING GUIDE |
| 03701037305676 | CENTERING GUIDE |
| 03701037305669 | K-WIRE GUIDE HANDLE |
| 03701037305652 | RING CUTTING GUIDE Ø50 mm |
| 03701037305645 | RING CUTTING GUIDE Ø46 mm |
| 03701037305638 | RING CUTTING GUIDE Ø43 mm |
| 03701037305621 | RING CUTTING GUIDE Ø39 mm |
| 03701037305591 | CUTTING GUIDE HANDLE |
| 03701037305560 | CUTTING GUIDE SCREW |
| 03701037305553 | HUMELOCK HEX 6/3.5mmSCREWDRIVER |
| 03701037305515 | HUMELOCK HEIGHT GAUGE SUPERIOR FLAT |
| 03701037305508 | THREADED K-WIRE Ø2.0 L180mm |
| 03701037305492 | K-WIRE Ø2.0mm L.180mm |
| 03701037304808 | HUMELOCK II TRIAL STEM T15 |
| 03701037304792 | HUMELOCK II TRIAL STEM T14 |