FX Solutions® 914-0709-CM1
GUDID 03701037314135
TRIAL FIXED HUMERAL CUP 135/145° STANDARD Ø40 +9
FX SOLUTIONS
Orthopaedic surgical procedure kit, non-medicated, reusable| Primary Device ID | 03701037314135 |
| NIH Device Record Key | 4637ad96-e781-495f-a319-315843ee1e15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FX Solutions® |
| Version Model Number | 914-0709-CM1 |
| Catalog Number | 914-0709-CM1 |
| 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 | 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701037314135 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150488
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
[03701037314135]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-04 |
| Device Publish Date | 2020-07-27 |
On-Brand Devices [FX Solutions®]
| 03701037312674 | HUDSON EXTENSION CONNECT |
| 03701037312667 | RATCHET T-HANDLE / HUDSON |
| 03701037312650 | HANDLE / HUDSON |
| 03701037312643 | RATCHET HANDLE / HUDSON |
| 03701037312636 | DRILLING GUIDE DEPTH GAUGE |
| 03701037312629 | LONG IMPACTEUR DE METAGLENE |
| 03701037312612 | 40/16 HUMELOCK REVERSED BROACH |
| 03701037312605 | 40/14 HUMELOCK REVERSED BROACH |
| 03701037312599 | 40/12 HUMELOCK REVERSED BROACH |
| 03701037312582 | 36/14 HUMELOCK REVERSED BROACH |
| 03701037312575 | 36/12 HUMELOCK REVERSED BROACH |
| 03701037312568 | 36/10 HUMELOCK REVERSED BROACH |
| 03701037312551 | 32/12 HUMELOCK REVERSED BROACH |
| 03701037312544 | 32/10 HUMELOCK REVERSED BROACH |
| 03701037312537 | 32/08 HUMELOCK REVERSED BROACH |
| 03701037312520 | HUMELOCK REVERSED SUPERIOR LATERAL CUTTING GUIDE |
| 03701037312513 | HUMELOCK REVERSED LEFT DELTO PECTORAL CUTTING GUIDE |
| 03701037312506 | HUMELOCK REVERSED RIGHT DELTO PECTORAL CUTTING GUIDE |
| 03701037312490 | 145° EXTRAMEDULLARIS DELTO PECTORAL CUTTING GUIDE |
| 03701037312483 | LARGE AIMER |
| 03701037312438 | SYMETRIC GLENOID WITH SPIKES K-WIRE GUIDE + TEMPLATE SIZE L |
| 03701037312421 | SYMETRIC GLENOID WITH SPIKES K-WIRE GUIDE + TEMPLATE SIZE M |
| 03701037312414 | SYMETRIC GLENOID WITH SPIKES K-WIRE GUIDE + TEMPLATE SIZE S |
| 03701037312407 | SYMETRIC GLENOID WITH SPIKES K-WIRE GUIDE + TEMPLATE SIZE XS |
| 03701037312391 | POSTERIOR GLENOID RETRACTOR |
| 03701037312384 | HUMELOCK REVERSED LEFT DELTO PECTORAL CUTTING GUIDE |
| 03701037312377 | 135° EXTRAMEDULLARIS DELTO PECTORAL CUTTING GUIDE |
| 03701037312360 | HUMELOCK REVERSED RIGHT DELTO PECTORAL CUTTING GUIDE |
| 03701037312353 | RASP HANDLE |
| 03701037312346 | LONG STOP DRILL BIT Ø7.5mm |
| 03701037312339 | HANDLE BIT / FX / HUDSON |
| 03701037312322 | LONG GUIDE Ø10mm |
| 03701037312315 | CANNULATED 3,5MM HEX. SCREWDRIVER BIT / HUDSON |
| 03701037312308 | STEM IMPACTOR |
| 03701037312292 | GLENOID RESURFACING REAMER Ø39 mm / FX |
| 03701037312285 | GLENOID RESURFACING REAMER Ø35 mm / FX |
| 03701037312278 | GLENOID RESURFACING REAMER Ø31 mm / FX |
| 03701037312261 | GLENOID RESURFACING REAMER Ø27 mm / FX |
| 03701037312254 | DRILL BIT Ø3,2mm L271mm/AO |
| 03701037312247 | STOP DRILL BIT Ø7.5 mm L.150 mm / HUDSON |
| 03701037312230 | STOP DRILL BIT Ø5.0 mm L.150 mm / HUDSON |
| 03701037312223 | STOP DRILL BIT Ø5.0 mm L.40 mm / FX |
| 03701037312216 | HANDLE BIT RELEASE/ FX / HUDSON |
| 03701037312209 | GLENOID RESURFACING REAMER Ø43 mm / FX |
| 03701037312193 | OFFSET SCREWED PROTECTOR Ø46mm |
| 03701037312186 | OFFSET SCREWED PROTECTOR Ø41mm |
| 03701037312155 | LONG GUIDES HOLDER |
| 03701037312148 | K-WIRE GUIDE WITH GAUGE |
| 03701037312131 | K-WIRE GUIDE WITHOUT GAUGE |
| 03701037312124 | GLENOID RESURFACING REAMER Ø36mm WITH DRILL /HUDSON |
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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