PARA CPX N/A

GUDID 00857915007606

PARA Cross Pin External Fixation Frame and One Tightening Tool

A.M. SURGICAL, INC.

External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile External orthopaedic fixation system, single-use, sterile

• Primary Device ID: 00857915007606
• NIH Device Record Key: 02e1310d-ee9c-4721-85af-d4a7656691fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARA CPX
• Version Model Number: 8800-10
• Catalog Number: N/A
• Company DUNS: 160020087
• Company Name: A.M. SURGICAL, INC.
• 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: true
• 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: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com
• Phone: 6319799777
• Email: vp@amsurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857915007606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042458

FDA Product Code

• LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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: 2021-01-19
• Device Publish Date: 2021-01-11

Devices Manufactured by A.M. SURGICAL, INC.

• 10857915007191 - Secure Screw 40mm: 2021-02-17 Secure Screw 40mm
• 00857915007248 - Secure Screw 45mm: 2021-02-17 Secure Screw 45mm
• 10857915007214 - Secure Screw 50mm: 2021-02-17 Secure Screw 50mm
• 00857915007255 - Secure Screw 55mm: 2021-02-17 Secure Screw 55mm
• 10857915007238 - Secure Screw 60mm: 2021-02-17 Secure Screw 60mm
• 00857915007262 - Secure Screw Starter Pack: 2021-02-17 Secure Screw Starter Pack
• 10857915007566 - Secure Screw 35mm: 2021-02-17 Secure Screw 35mm
• 00857915007606 - PARA CPX: 2021-01-19PARA Cross Pin External Fixation Frame and One Tightening Tool
• 00857915007606 - PARA CPX: 2021-01-19 PARA Cross Pin External Fixation Frame and One Tightening Tool