Apex

GUDID 05391529581459

Tibial Insertion Handle

ORTHOXEL DESIGNATED ACTIVITY COMPANY

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 05391529581459
• NIH Device Record Key: 526bc18a-f1f8-41d6-8d34-3734be6c34c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apex
• Version Model Number: INS-1003
• Company DUNS: 985596830
• Company Name: ORTHOXEL DESIGNATED ACTIVITY COMPANY
• 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: 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: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391529581459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170972

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

[05391529581459]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-10
• Device Publish Date: 2019-10-02

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