HUMELOCK REVERSED 317-3612
GUDID 03701037303740
HUMELOCK REVERSED STEM TA6V Ø36/12 CEMENTLESS LOCKABLE Ti/HA
FX SOLUTIONS
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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