EPIX AntiRotation Device 3315-00000

GUDID B2213315000001

Intramedullary And Accessories

Epix Orthopaedics Inc.

Flexible bone nail, sterile

• Primary Device ID: B2213315000001
• NIH Device Record Key: 9bbb04f2-3d27-4e97-8706-9d024f3711cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIX AntiRotation Device
• Version Model Number: 3315-00000
• Catalog Number: 3315-00000
• Company DUNS: 084913303
• Company Name: Epix Orthopaedics Inc.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)710-9105
• Email: epixortho@icloud.com
• Phone: +1(844)710-9105
• Email: epixortho@icloud.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2213315000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133104

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[B2213315000001]

Moist Heat or Steam Sterilization

[B2213315000001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-13
• Device Publish Date: 2019-03-05

Devices Manufactured by Epix Orthopaedics Inc.

• B2215000000200 - EPIX Angle Setting Fixture and Lag Screw Pointer: 2020-04-06 Surgical instrument guide
• B2215000000400 - EPIX DTS Bolt: 2020-04-06 Surgical instrument guide
• B2215000000500 - EPIX DTS Bolt Driver: 2020-04-06 Surgical instrument guide
• B2215000000600 - EPIX DTS (Dynamic Targeting System): 2020-04-06 Surgical instrument guide
• B2215000000700 - EPIX Lag Screw Trial: 2020-04-06 Surgical instrument guide
• B2215000000900 - EPIX Ball Tipped Guide Wire: 2020-04-06 Surgical instrument guide
• B2215000001200 - EPIX Proximal Reamer Sleeve: 2020-04-06 Surgical instrument guide
• B2215000001300 - EPIX Off Set Proximal Reamer Sleeve: 2020-04-06 Surgical instrument guide