ORTHOFIX
GUDID 18052469475966
ORTHOFIX SRL
External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use| Primary Device ID | 18052469475966 |
| NIH Device Record Key | b775397f-ff2b-44bb-b02d-603a8b908084 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOFIX |
| Version Model Number | 1 |
| Company DUNS | 438793622 |
| Company Name | ORTHOFIX SRL |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it | |
| Phone | +0390456719000 |
| info@orthofix.it |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18052469475966 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K941048
FDA Product Code
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
[18052469475966]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-08 |
| Device Publish Date | 2024-01-31 |
On-Brand Devices [ORTHOFIX]
| 18053800898710 | JPS MODULAR TRAY LID |
| 18053800898703 | JPS MODULAR BASE 5.0MM INSTRUMENT |
| 18053800898697 | JPS MODULAR BASE 3.5MM INSTRUMENT |
| 18053800898680 | JPS MODULAR BASE 3.0MM INSTRUMENT |
| 18053800898673 | JPS MODULAR BASE GENERAL INSTRUMENT |
| 18053800898666 | JPS MUDULAR TRAY COMPLETE |
| 18053800898543 | SS MEDIALIZATION GUIDE BODY 5.0MM |
| 18053800898536 | SS MEDIALIZATION GUIDE BODY 3.5MM |
| 18053800898529 | SS MEDIALIZATION GUIDE MECHANISM |
| 18053800898512 | SS LARGE BONE CLAMP |
| 18053800898505 | SS SMALL BONE CLAMP |
| 18053800898499 | AL DOUBLE MEASURING DEVICE |
| 18053800898482 | SS OSTEOTOMY GAUGE |
| 18053800898475 | AL ANGLED WIRE GUIDE 3.0MM PLATE |
| 18053800898468 | SS AIMING BLOCK 3.5MM PLATE |
| 18053800898451 | SS AIMING BLOCK 5.0MM PLATE |
| 18053800898444 | ALANGLED WIRE GUIDE 3.5 AND 5.0MM PLATES |
| 18053800898437 | SS TRIANGULAR POSITIONING PLATE 90° 50° 40° |
| 18053800898420 | SS TRIANGULAR POSITIONING PLATE 70° 80° 30° |
| 18053800898413 | SS TRIANGULAR POSITIONING PLATE 60° 100° 20° |
| 18053800898376 | SS T15 RETENTIVE SCREWDRIVER QUICK CONNECT |
| 18053800898369 | SS T10 RETENTIVE SCREWDRIVER QUICK CONNECT |
| 18053800898352 | SS T8 RETENTIVE SCREWDRIVER QUICK CONNECT |
| 18053800898345 | SS DRILL GUIDE NON LOCKING D3.4MM |
| 18053800898338 | SS DRILL GUIDE NON LOCKING D2.8MM |
| 18053800898321 | SS DRILL GUIDE NON LOCKING D2.3MM |
| 18053800898314 | SS DRILL BIT D4.3MM QUICK CONNECT |
| 18053800898307 | SS DRILL BIT D3.4MM QUICK CONNECT |
| 18053800898291 | SS DRILL BIT D2.8MM QUICK CONNECT |
| 18053800898284 | SS DRILL BIT D2.3MM QUICK CONNECT |
| 18053800898277 | SS REDUCTION SLEEVE |
| 18053800898260 | SS DRILL GUIDE LOCKING D4.3MM |
| 18053800898253 | SS DRILL GUIDE LOCKING D2.8MM |
| 18053800898246 | SS DRILL GUIDE LOCKING D2.3MM |
| 18053800898192 | SS GUIDE WIRE D2.0MM L200MM PACK OF 2 |
| 18053340340434 | SS JPS TEMPLATE |
| 18053800898604 | SS T15 EXTRACTION SCREWDRIVER |
| 18053800898598 | SS T10 EXTRACTION SCREWDRIVER |
| 18053800898581 | SS T8 EXTRACTION SCREWDRIVER |
| 18053800898567 | SS T10-T15 CONICAL EXTRACTOR |
| 18053800898550 | SS T8 CONICAL EXTRACTOR |
| 18053800898239 | SS GUIDE WIRE D4.3MM L190MM PACK OF 2 |
| 18053800898222 | SS GUIDE WIRE D3.4MM L200MM PACK OF 2 |
| 18053800898215 | SS GUIDE WIRE D2.8MM L200MM PACK OF 2 |
| 18059015372939 | G-BEAM SIZING GAUGE |
| 18033509857898 | SMN SYSTEM SLIDING HAMMER ASSEMBLY |
| 18052469475966 | 1 |
| 18059015370553 | FITBONE TRANSPORT NAIL TN 1340-F-R-490 STERILE |
| 18059015370546 | FITBONE TRANSPORT NAIL TN 1340-F-R-470 STERILE |
| 18059015370539 | FITBONE TRANSPORT NAIL TN 1340-F-R-450 STERILE |
Trademark Results [ORTHOFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOFIX 85740258 4720572 Live/Registered |
Orthofix Srl 2012-09-27 |
 ORTHOFIX 85534194 not registered Dead/Abandoned |
Bonafix Surgical and Dental Implants, LLC 2012-02-05 |
 ORTHOFIX 78427227 3004080 Live/Registered |
DYNASTY CONSOLIDATED INDUSTRIES, INC. 2004-05-28 |
 ORTHOFIX 75326029 not registered Dead/Abandoned |
Binder Kletten-Haftverschlub-Systeme GmbH 1997-07-17 |
 ORTHOFIX 73471468 1310950 Live/Registered |
Orthofix S.r.l. 1984-03-21 |
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