HUMELOCK REVERSED 317-3612
GUDID 03701037303740
HUMELOCK REVERSED STEM TA6V Ø36/12 CEMENTLESS LOCKABLE Ti/HA
FX SOLUTIONS
Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis Uncoated shoulder humeral stem prosthesis| Primary Device ID | 03701037303740 |
| NIH Device Record Key | b6ea6212-ade9-46a9-b53c-20fd3047e3b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HUMELOCK REVERSED |
| Version Model Number | Ø36/12 CEMENTLESS LOCKABLE |
| Catalog Number | 317-3612 |
| 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 | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
| Outer Diameter | 21 Millimeter |
| Outer Diameter | 32 Millimeter |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037303740 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162455
FDA Product Code
| PHX | Shoulder Prosthesis, Reverse Configuration |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-02-28 |
| Device Publish Date | 2017-01-31 |
On-Brand Devices [HUMELOCK REVERSED]
| 03701037308004 | TRIAL CENTERED TAPER ADAPTER Ø24 / Ø10 |
| 03701037307991 | TRIAL ECCENTRIC TAPER ADAPTER Ø24 / Ø10 |
| 03701037307946 | TRIAL HUMELOCK REVERSED STEM Ø36/16 |
| 03701037307861 | TRIAL HUMELOCK REVERSED STEM Ø32/16 |
| 03701037307854 | TRIAL HUMELOCK REVERSED STEMI Ø32/14 |
| 03701037303740 | HUMELOCK REVERSED STEM TA6V Ø36/12 CEMENTLESS LOCKABLE Ti/HA |
Trademark Results [HUMELOCK REVERSED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HUMELOCK REVERSED 87622188 5573371 Live/Registered |
FX Solutions 2017-09-26 |
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