Apex F05-110260

GUDID 05391529587994

Apex Femoral Nail Retrograde Ø 11.0 x 260mm

ORTHOXEL DESIGNATED ACTIVITY COMPANY

Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: 05391529587994
• NIH Device Record Key: 4bffe12f-461a-4cdb-8d23-e1274b720399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apex
• Version Model Number: F05-110260
• Catalog Number: F05-110260
• Company DUNS: 985596830
• Company Name: ORTHOXEL DESIGNATED ACTIVITY COMPANY
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com
• Phone: 646-661-3167
• Email: customercare@orthoxel.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Storage and Handling

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391529587994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181375

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

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: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [Apex]

• 05391529580797: Apex Tibial Endcap
• 05391529580780: Apex Tibia Endcap
• 05391529580773: Apex Tibial Endcap
• 05391529580582: Apex Tibial Nail, Sterile
• 05391529580193: Apex Tibia Screw, Sterile
• 05391529580186: Apex Tibial Screw, Sterile
• 05391529580179: Apex Tibial Screw, Sterile
• 05391529580162: Apex Tibial Screw, Sterile
• 05391529580155: Apex Tibial Screw, Sterile
• 05391529580148: Apex Tibial Screw, Sterile
• 05391529582180: Tibial Extraction Bolt
• 05391529581459: Tibial Insertion Handle
• 05391529581237: Tibial Radiolucent Guide ML
• 05391529581114: Tibial Insertion Bolt
• 05391529585150: Apex Tibial Nailing System Case
• 05391529584245: Yellow Ø4.25mm Drill Sleeve (Length 138.5mm)
• 05391529584238: Trocar Ø8.0mm x Length 150.0mm
• 05391529584221: Green Outer Drill Sleeve (Length 129mm)
• 05391529584214: Suprapatellar AO Mount Anchor Pin
• 05391529584207: AO Mount Drill Extension (Length 136.5mm)
• 05391529584191: Suprapatellar Trocar
• 05391529584184: Suprapatellar K-Wire Guide
• 05391529584177: Suprapatellar Standard Protection Sleeve
• 05391529584160: Suprapatellar Anchoring Protection Sleeve
• 05391529584153: Suprapatellar Protection Sleeve Handle Connector
• 05391529584146: Suprapatellar Protection Sleeve Handle
• 05391529584139: Tibial Suprapatellar Connecting Bolt
• 05391529584122: Tibial Suprapatellar Insert Retainer
• 05391529584115: Tibial Infrapatellar Connecting Bolt
• 05391529584108: Tibial Infrapatellar Insert Retainer
• 05391529584092: Tibial Targeting Guide Locking Bolt
• 05391529584085: Tibial Targeting Guide
• 05391529584078: Tibial Suprapatellar Insertion Handle
• 05391529584061: Tibial Infrapatellar Insertion Handle
• 05391529584054: Ø12 Cannulated Curved Awl
• 05391529583149: Large AO T-Handle
• 05391529583125: Insert Retainer Containing Bolt
• 05391529583101: Monobloc Reamer, Size 8.0
• 05391529583095: Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw)
• 05391529583088: Monobloc Reamer, Size 7.0
• 05391529583071: Locking Screw Length Gauge (Hook)
• 05391529583064: Monobloc Reamer, Size 6.0
• 05391529583057: Flexible IM reamer Shaft 470mm
• 05391529583040: Modular Reamer Head, Size 16.0
• 05391529583033: Modular Reamer Head, Size 15.5
• 05391529583026: Modular Reamer Head, Size 15.0
• 05391529583019: Modular Reamer Head, Size 14.5
• 05391529583002: Modular Reamer Head, Size 14.0
• 05391529582999: Modular Reamer Head, Size 13.5
• 05391529582982: Modular Reamer Head, Size 13.0