Unity SIT.912565

GUDID 08800113960343

Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)65x(B)12.5x(C)2.9x(D)2.6x(E)10.5x(F)6.3mm

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800113960343
• NIH Device Record Key: 0ca06950-2e5f-4973-8a1c-92621d526d46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unity
• Version Model Number: A
• Catalog Number: SIT.912565
• Company DUNS: 557795909
• Company Name: DIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800113960343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173201

FDA Product Code

• OUR: Sacroiliac joint fixation

Sterilization

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

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

[08800113960343]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-26
• Device Publish Date: 2021-03-18

On-Brand Devices [Unity]

• 08800039822329: SIJ Guide
• 08800039822282: SIJ K-WIRE HOLDER
• 08800039830577: SIJ SCREW_ADD HOLE 12.5 x 50
• 08800039830560: SIJ SCREW_ADD HOLE 12.5 x 45
• 08800039830539: SIJ SCREW_ADD HOLE 12.5 x 55
• 08800039830522: SIJ SCREW_ADD HOLE 12.5 x 60
• 08800039830515: SIJ SCREW_ADD HOLE 12.5 x 40
• 08800113960459: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (CoCr) - Double & Self Tapping (A)62.5x(B)9.
• 08800113960442: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (CoCr) - Double & Self Tapping (A)57.5x(B)9.
• 08800113960435: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (CoCr) - Double & Self Tapping (A)52.5x(B)9.
• 08800113960428: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (CoCr) - Double & Self Tapping (A)47.5x(B)9.
• 08800113960411: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (CoCr) - Double & Self Tapping (A)42.5x(B)9.
• 08800113960404: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (Ti) - Double & Self Tapping (A)62.5x(B)9.5x
• 08800113960398: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (Ti) - Double & Self Tapping (A)57.5x(B)9.5x
• 08800113960381: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (Ti) - Double & Self Tapping (A)52.5x(B)9.5x
• 08800113960374: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (Ti) - Double & Self Tapping (A)47.5x(B)9.5x
• 08800113960367: Unity Sacroiliac Joint Fixation - Lag SIJ Screw II (Ti) - Double & Self Tapping (A)42.5x(B)9.5x
• 08800113960350: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)70x(
• 08800113960343: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)65x(
• 08800113960336: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)60x(
• 08800113960329: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)55x(
• 08800113960312: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)50x(
• 08800113960305: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)45x(
• 08800113960299: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)40x(
• 08800113960282: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)35x(
• 08800113960275: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)30x(
• 08800113960268: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)70x(
• 08800113960251: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)65x(
• 08800113960244: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)60x(
• 08800113960237: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)55x(
• 08800113960220: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)50x(
• 08800113960213: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)45x(
• 08800113960206: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)40x(
• 08800113960190: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)35x(
• 08800113960183: Unity Sacroiliac Joint Fixation - Threaded Countersunk SIJ Screw - Double & Self Tapping (A)30x(
• 08800113999602: Unity Erodium SIJ Headless Compression Screw - OD13.5xL70
• 08800113999596: Unity Erodium SIJ Headless Compression Screw - OD13.5xL65
• 08800113999589: Unity Erodium SIJ Headless Compression Screw - OD13.5xL60
• 08800113999572: Unity Erodium SIJ Headless Compression Screw - OD13.5xL55
• 08800113999565: Unity Erodium SIJ Headless Compression Screw - OD13.5xL50
• 08800113999558: Unity Erodium SIJ Headless Compression Screw - OD13.5xL45
• 08800113999541: Unity Erodium SIJ Headless Compression Screw - OD13.5xL40
• 08800113999534: Unity Erodium SIJ Headless Compression Screw - OD13.5xL35
• 08800113999527: Unity Erodium SIJ Headless Compression Screw - OD13.5xL30
• 08800113999510: Unity Erodium SIJ Headless Compression Screw - OD11.5xL70
• 08800113999503: Unity Erodium SIJ Headless Compression Screw - OD11.5xL65
• 08800113999497: Unity Erodium SIJ Headless Compression Screw - OD11.5xL60
• 08800113999480: Unity Erodium SIJ Headless Compression Screw - OD11.5xL55
• 08800113999473: Unity Erodium SIJ Headless Compression Screw - OD11.5xL50
• 08800113999466: Unity Erodium SIJ Headless Compression Screw - OD11.5xL45