FX Solutions 116-4818
GUDID 03701037300916
CENTERED HEAD CoCr/TiN 48x18
FX SOLUTIONS
Stem-fixed humeral head prosthesis| Primary Device ID | 03701037300916 |
| NIH Device Record Key | f911c021-6d29-4008-8e3b-a8dea21399c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FX Solutions |
| Version Model Number | 116-4818 |
| Catalog Number | 116-4818 |
| 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 |
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 |
| 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 | 03701037300916 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191698
FDA Product Code
| PHX | Shoulder Prosthesis, Reverse Configuration |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-29 |
| Device Publish Date | 2020-07-21 |
On-Brand Devices [FX Solutions]
| 03701037308561 | TRIAL HUMERAL CUP 135/145° STANDARD Ø32 +9 |
| 03701037308554 | TRIAL HUMERAL CUP 135/145° STANDARD Ø32 +6 |
| 03701037308547 | TRIAL HUMERAL CUP 135/145° STANDARD Ø32 +3 |
| 03701037308530 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø32 +9 |
| 03701037308523 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø32 +6 |
| 03701037308516 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø32 +3 |
| 03701037308479 | TRIAL HUMERAL CUP STANDARD Ø32+9 |
| 03701037308462 | TRIAL HUMERAL CUP STANDARD Ø32+6 |
| 03701037308455 | TRIAL HUMERAL CUP STANDARD Ø32+3 |
| 03701037308448 | TRIAL HUMERAL CUP MOBILITY Ø32+9 |
| 03701037308431 | TRIAL HUMERAL CUP MOBILITY Ø32+6 |
| 03701037308424 | TRIAL HUMERAL CUP MOBILITY Ø32+3 |
| 03701037308417 | TRIAL HUMERAL CUP MOBILITY Ø36+9 |
| 03701037308400 | TRIAL HUMERAL CUP MOBILITY Ø36+6 |
| 03701037308394 | TRIAL HUMERAL CUP MOBILITY Ø36+3 |
| 03701037308264 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø40 +9 |
| 03701037308257 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø40 +6 |
| 03701037308240 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø40 +3 |
| 03701037308233 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø36 +9 |
| 03701037308226 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø36 +6 |
| 03701037308219 | TRIAL HUMERAL CUP 135/145° MOBILITY Ø36 +3 |
| 03701037308035 | TRIAL HUMERAL CUP MOBILITY Ø40+9 |
| 03701037308028 | TRIAL HUMERAL CUP MOBILITY Ø40+6 |
| 03701037308011 | TRIAL HUMERAL CUP MOBILITY Ø40+3 |
| 03701037307915 | TRIAL OFFSET GLENOSPHERE Ø32 |
| 03701037307878 | TRIAL CENTERED GLENOSPHERE Ø32 |
| 03701037300312 | Humelock II Reversible Shoulder, HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10Â |
| 03701037300305 | Humelock II Reversible Shoulder, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° |
| 03701037300299 | Humelock II Reversible Shoulder, HUMELOCK REVERSED ECCENTRIC GLENOSPHERE CoCr 10° TILT Ø40 mm |
| 03701037300282 | Humelock II Reversible Shoulder, HUMELOCK REVERSED CENTERED GLENOSPHERE CoCr 10° TILT Ø40 mm |
| 03701037300275 | Humelock II Reversible Shoulder, HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10Â |
| 03701037300268 | Humelock II Reversible Shoulder, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° |
| 03701037300251 | Humelock II Reversible Shoulder, HUMELOCK REVERSED ECCENTRIC GLENOSPHERE CoCr 10° TILT Ø36 mm |
| 03701037300244 | Humelock II Reversible Shoulder, HUMELOCK REVERSED CENTERED GLENOSPHERE CoCr 10° TILT Ø36 mm |
| 03701037300237 | Humelock II Reversible Shoulder, HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE Ti/HA Ø24 |
| 03701037300190 | Humelock II Cemented Shoulder System, 2 PEGS GLENOID PE CEMENTED SIZE L |
| 03701037300183 | Humelock II Cemented Shoulder System, 2 PEGS GLENOID PE CEMENTED SIZE M |
| 03701037300176 | Humelock II Cemented Shoulder System, 2 PEGS GLENOID PE CEMENTED SIZE S |
| 03701037300169 | Humelock II Cemented Shoulder System, 2 PEGS GLENOID PE CEMENTED SIZE XS |
| 03701037309421 | HUMERAL CUP STABILITY PE/TA6V Ø36/+6 |
| 03701037309414 | HUMERAL CUP STABILITY PE/TA6V Ø36/+3 |
| 03701037313374 | CENTRAL SCREW TA6V Ø4.5mm L.20mm |
| 03701037313367 | CENTRAL SCREW TA6V Ø4.5mm L.18mm |
| 03701037313350 | CENTRAL SCREW TA6V Ø4.5mm L.16mm |
| 03701037313343 | CENTRAL SCREW TA6V Ø4.5mm L.14mm |
| 03701037313336 | CENTRAL SCREW TA6V Ø4.5mm L.12mm |
| 03701037313329 | CENTRAL SCREW TA6V Ø4.5mm L.10mm |
| 03701037313312 | CENTRAL SCREW TA6V Ø4.5mm L.08mm |
| 03701037313305 | HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm |
| 03701037302675 | Humelock II Reversible Shoulder, STANDARD SCREW TA6V Ø4.5mm L.58 mm |
Trademark Results [FX Solutions]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FX SOLUTIONS 85051685 3868904 Live/Registered |
Martin, Jean-Jacques 2010-06-01 |
 FX SOLUTIONS 76169956 2671110 Live/Registered |
GAIN CAPITAL UK LIMITED 2000-11-22 |
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