E01-000

GUDID 05391529580766

Apex Tibial Endcap

ORTHOXEL DESIGNATED ACTIVITY COMPANY

Bone nail end-cap, sterile

• Primary Device ID: 05391529580766
• NIH Device Record Key: cba649b2-1c09-499f-b612-fdd49df0f8dc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: E01-000
• Catalog Number: E01-000
• 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: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Ambient Temperature and Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391529580766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170972

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2019-06-14
• Device Publish Date: 2019-06-06

Devices Manufactured by ORTHOXEL DESIGNATED ACTIVITY COMPANY

• 05391529588786 - Apex: 2023-07-19 Long Reamer Case
• 05391529588793 - Apex: 2023-07-19 Long Reaming Kit
• 05391543064273 - Apex: 2023-07-19 Large AO to ZIH Adapter
• 05391529587970 - Apex: 2023-07-18 Apex Femoral Nail Retrograde Ø 10.0 x 460mm
• 05391529587987 - Apex: 2023-07-18 Apex Femoral Nail Retrograde Ø 11.0 x 240mm
• 05391529587994 - Apex: 2023-07-18 Apex Femoral Nail Retrograde Ø 11.0 x 260mm
• 05391529588007 - Apex: 2023-07-18 Apex Femoral Nail Retrograde Ø 11.0 x 280mm
• 05391529588014 - Apex: 2023-07-18 Apex Femoral Nail Retrograde Ø 11.0 x 300mm