| Primary Device ID | 18053340348331 | 
| NIH Device Record Key | 3e1c9bba-3408-4e2e-aa17-7ffcf2997e80 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SOLE MEDIAL COLUMN FUSION PLATE | 
| Version Model Number | 1 | 
| Catalog Number | 842555 | 
| Company DUNS | 438793622 | 
| Company Name | ORTHOFIX SRL | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| 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 | |
| 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 | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Outer Diameter | 5 Millimeter | 
| Length | 55 Millimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 18053340348331 [Primary] | 
| HWC | Screw, Fixation, Bone | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
[18053340348331]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-06-11 | 
| Device Publish Date | 2021-06-03 | 
| 18053340348652 | SOLE MCF TRAY COMPLETE EMPTY | 
| 18053340348522 | SS NON-LOCKING SCREW L60MM D4MM | 
| 18053340348515 | SS NON-LOCKING SCREW L55MM D4MM | 
| 18053340348508 | SS NON-LOCKING SCREW L50MM D4MM | 
| 18053340348492 | SS NON-LOCKING SCREW L46MM D4MM | 
| 18053340348485 | SS NON-LOCKING SCREW L42MM D4MM | 
| 18053340348478 | SS NON-LOCKING SCREW L38MM D4MM | 
| 18053340348461 | SS NON-LOCKING SCREW L34MM D4MM | 
| 18053340348454 | SS NON-LOCKING SCREW L30MM D4MM | 
| 18053340348447 | SS NON-LOCKING SCREW L28MM D4MM | 
| 18053340348430 | SS NON-LOCKING SCREW L26MM D4MM | 
| 18053340348423 | SS NON-LOCKING SCREW L24MM D4MM | 
| 18053340348416 | SS NON-LOCKING SCREW L22MM D4MM | 
| 18053340348409 | SS NON-LOCKING SCREW L20MM D4MM | 
| 18053340348393 | SS NON-LOCKING SCREW L18MM D4MM | 
| 18053340348386 | SS NON-LOCKING SCREW L16MM D4MM | 
| 18053340348379 | SS NON-LOCKING SCREW L14MM D4MM | 
| 18053340348362 | SS NON-LOCKING SCREW L12MM D4MM | 
| 18053340348355 | SS NON-LOCKING SCREW L10MM D4MM | 
| 18053340348348 | SS NON-LOCKING SCREW L60MM D5MM | 
| 18053340348331 | SS NON-LOCKING SCREW L55MM D5MM | 
| 18053340348324 | SS NON-LOCKING SCREW L50MM D5MM | 
| 18053340348317 | SS NON-LOCKING SCREW L46MM D5MM | 
| 18053340348300 | SS NON-LOCKING SCREW L42MM D5MM | 
| 18053340348294 | SS NON-LOCKING SCREW L38MM D5MM | 
| 18053340348287 | SS NON-LOCKING SCREW L34MM D5MM | 
| 18053340348270 | SS NON-LOCKING SCREW L30MM D5MM | 
| 18053340348263 | SS NON-LOCKING SCREW L28MM D5MM | 
| 18053340348256 | SS NON-LOCKING SCREW L26MM D5MM | 
| 18053340348249 | SS NON-LOCKING SCREW L24MM D5MM | 
| 18053340348232 | SS NON-LOCKING SCREW L22MM D5MM | 
| 18053340348225 | SS NON-LOCKING SCREW L20MM D5MM | 
| 18053340348218 | SS NON-LOCKING SCREW L18MM D5MM | 
| 18053340348201 | SS NON-LOCKING SCREW L16MM D5MM | 
| 18053340348195 | SS NON-LOCKING SCREW L14MM D5MM | 
| 18053340348188 | SS NON-LOCKING SCREW L12MM D5MM | 
| 18053340348171 | SS NON-LOCKING SCREW L10MM D5MM | 
| 18053340348164 | SS VA LOCKING SCREW L60MM D4MM | 
| 18053340348157 | SS VA LOCKING SCREW L55MM D4MM | 
| 18053340348140 | SS VA LOCKING SCREW L50MM D4MM | 
| 18053340348133 | SS VA LOCKING SCREW L46MM D4MM | 
| 18053340348126 | SS VA LOCKING SCREW L42MM D4MM | 
| 18053340348119 | SS VA LOCKING SCREW L38MM D4MM | 
| 18053340348102 | SS VA LOCKING SCREW L34MM D4MM | 
| 18053340348096 | SS VA LOCKING SCREW L30MM D4MM | 
| 18053340348089 | SS VA LOCKING SCREW L28MM D4MM | 
| 18053340348072 | SS VA LOCKING SCREW L26MM D4MM | 
| 18053340348065 | SS VA LOCKING SCREW L24MM D4MM | 
| 18053340348058 | SS VA LOCKING SCREW L22MM D4MM | 
| 18053340348041 | SS VA LOCKING SCREW L20MM D4MM |