ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OS OS312040

GUDID 05055662900767

OPENING WEDGE OSTEOTOMY PLATE 4.0MM

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 05055662900767
• NIH Device Record Key: 09b71023-a79f-4d7d-ba09-59324f3f561b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OS
• Version Model Number: OS312040
• Catalog Number: OS312040
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com
• Phone: +441621843599
• Email: quality@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662900767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111678

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-11

On-Brand Devices [ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OS]

• 05055662935264: K-WIRE TROCAR TIP 1.0MM X 70MM
• 05055662935226: FOS GUIDE WIRE 0.8MM X 80MM TROCAR TIP
• 05055662935196: META GUIDE WIRE 1.0MM X 70MM DOUBLE TROCAR
• 05055662932966: FOS SOLID 2.0MM DRILL
• 05055662932751: AO QC COMPRESSION SCREW DRILL 22MM
• 05055662932713: AO QC COMPRESSION SCREW DRILL 12MM
• 05055662932690: AO QC COMPRESSION SCREW DRILL 18MM
• 05055662929300: MEMO STAPLE LONG POST 2.4MM X 75MM
• 05055662929263: MEMO STAPLE 20MM/25MM TEMPLATE
• 05055662928952: SCARF SCREW DRIVER SHANK
• 05055662928938: FOS BONE HOLDING FORCEPS
• 05055662928907: FOS AO QC HANDLE
• 05055662928884: WEIL SCREW SOLID DRIVER SHANK
• 05055662928877: 2.3MM PHALANGEAL SCREW CANNULATED DRIVER SHANK
• 05055662928341: COMPRESSION STAPLE IMPACTOR
• 05055662928327: META SCREW BACKHAUS FORCEPS
• 05055662923742: FPS 2.7MM TORX DRIVER
• 05055662923735: FPS 3.5MM CANNULATED HEXAGONAL SCREWDRIVER
• 05055662923469: FOOT RECONSTRUCTION SYSTEM STERILISATION TRAY (FRS)
• 05055662918168: MEMO STAPLE 10MM/12MM/16MM TEMPLATE
• 05055662917376: WASHER 7.0MM/3.6MM
• 05055662917352: FPS 3.5MM WASHER
• 05055662917215: VARISATION STAPLE 26 DEGREE 8MM WIDE
• 05055662917192: VARISATION STAPLE 90 DEGREE 8MM WIDE
• 05055662917178: VARISATION STAPLE 26 DEGREE 10MM WIDE
• 05055662917154: VARISATION STAPLE 90 DEGREE 10MM WIDE
• 05055662917130: VARISATION COMPRESSION STAPLE 10MM WIDE
• 05055662909746: FPS 2.7MM NON-LOCKING SCREW 30MM
• 05055662909722: FPS 2.7MM NON-LOCKING SCREW 28MM
• 05055662909708: FPS 2.7MM NON-LOCKING SCREW 26MM
• 05055662909685: FPS 2.7MM NON-LOCKING SCREW 24MM
• 05055662909661: FPS 2.7MM NON-LOCKING SCREW 22MM
• 05055662909647: FPS 2.7MM NON-LOCKING SCREW 20MM
• 05055662909623: FPS 2.7MM NON-LOCKING SCREW 18MM
• 05055662909609: FPS 2.7MM NON-LOCKING SCREW 16MM
• 05055662909586: FPS 2.7MM NON-LOCKING SCREW 14MM
• 05055662909562: FPS 2.7MM NON-LOCKING SCREW 12MM
• 05055662909548: FPS 2.7MM NON-LOCKING SCREW 10MM
• 05055662909524: FPS 2.7MM NON-LOCKING SCREW 8MM
• 05055662909500: FPS 2.7MM LOCKING SCREW 30MM
• 05055662909487: FPS 2.7MM LOCKING SCREW 28MM
• 05055662909463: FPS 2.7MM LOCKING SCREW 26MM
• 05055662909449: FPS 2.7MM LOCKING SCREW 24MM
• 05055662909425: FPS 2.7MM LOCKING SCREW 22MM
• 05055662909401: FPS 2.7MM LOCKING SCREW 20MM
• 05055662909371: FPS 2.7MM LOCKING SCREW 18MM
• 05055662909364: FPS 2.7MM LOCKING SCREW 16MM
• 05055662909340: FPS 2.7MM LOCKING SCREW 14MM
• 05055662909319: FPS 2.7MM LOCKING SCREW 12MM
• 05055662909302: FPS 2.7MM LOCKING SCREW 10MM