CyclaPlex Screwdriver SD-9221

GUDID 07290017626222

The Screwdriver is intended to assist in threading the implant into the bone.

ALPHAMET LTD

Surgical screwdriver, reusable

• Primary Device ID: 07290017626222
• NIH Device Record Key: 0f7f8dad-aa81-48aa-8410-4c640999e6d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CyclaPlex Screwdriver
• Version Model Number: V7
• Catalog Number: SD-9221
• Company DUNS: 600372473
• Company Name: ALPHAMET LTD
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (260) 438-2198
• Email: bcoburn@genorthopartners.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017626222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183094

FDA Product Code

• HTN: Washer, Bolt Nut

Sterilization

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

[07290017626222]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-20
• Device Publish Date: 2020-02-12

Devices Manufactured by ALPHAMET LTD

• 07290017626826 - CyclaPlex Implant: 2020-02-20 The implant is comprised of two metallic bone screws ("Anchor1", "Anchor 2") connected by an UHMW polyethylene multiple suture c
• 07290017626116 - CyclaPlex Correction System Instruments Case: 2020-02-20 The anodized aluminum Instruments Case is intended to accommodate the CyclaPlex surgery instruments in the right position for st
• 07290017626123 - CyclaPlex Correction System Instruments Case Set: 2020-02-20 The CyclaPlex Correction System Instruments Case Set is comprised of the following instruments delivered together. Instruments C
• 07290017626161 - CyclaPlex Drill Bits 1.8-3.0: 2020-02-20 The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant.
• 07290017626192 - CyclaPlex Drill Guide: 2020-02-20 The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles
• 07290017626222 - CyclaPlex Screwdriver: 2020-02-20The Screwdriver is intended to assist in threading the implant into the bone.
• 07290017626222 - CyclaPlex Screwdriver: 2020-02-20 The Screwdriver is intended to assist in threading the implant into the bone.