EVOL®SI Joint Fusion System

GUDID 00841193112244

10.5mm x 45mm EVOL®SI Screw, 3.2

Cutting Edge Spine, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: 00841193112244
• NIH Device Record Key: 53e2f946-b872-43b7-b42c-2b1375084e00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOL®SI Joint Fusion System
• Version Model Number: 5005-045T-32
• Company DUNS: 069472647
• Company Name: Cutting Edge Spine, LLC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841193112244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190025

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

[00841193112244]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [EVOL®SI Joint Fusion System]

• 00841193122991: EVOL®SI, 11.5mm Washer
• 00841193122984: EVOL®SI, 10.5mm Washer
• 00841193122977: EVOL®SI, 9.5mm Washer
• 00841193122960: EVOL®SI, 7.5mm Washer
• 00841193122953: 11.5mm x 060mm EVOL®SI Screw
• 00841193122946: 11.5mm x 055mm EVOL®SI Screw
• 00841193122939: 11.5mm x 050mm EVOL®SI Screw
• 00841193122922: 11.5mm x 045mm EVOL®SI Screw
• 00841193122915: 11.5mm x 040mm EVOL®SI Screw
• 00841193122908: 11.5mm x 035mm EVOL®SI Screw
• 00841193122892: 11.5mm x 030mm EVOL®SI Screw
• 00841193122885: 11.5mm x 025mm EVOL®SI Screw
• 00841193122878: 10.5mm x 060mm EVOL®SI Screw
• 00841193122861: 10.5mm x 055mm EVOL®SI Screw
• 00841193122854: 10.5mm x 050mm EVOL®SI Screw
• 00841193122847: 10.5mm x 045mm EVOL®SI Screw
• 00841193122830: 10.5mm x 040mm EVOL®SI Screw
• 00841193122823: 10.5mm x 035mm EVOL®SI Screw
• 00841193122816: 10.5mm x 030mm EVOL®SI Screw
• 00841193122809: 10.5mm x 025mm EVOL®SI Screw
• 00841193122793: 9.5mm x 060mm EVOL®SI Screw
• 00841193122786: 9.5mm x 055mm EVOL®SI Screw
• 00841193122779: 9.5mm x 050mm EVOL®SI Screw
• 00841193122762: 9.5mm x 045mm EVOL®SI Screw
• 00841193122755: 9.5mm x 040mm EVOL®SI Screw
• 00841193122748: 9.5mm x 035mm EVOL®SI Screw
• 00841193122731: 9.5mm x 030mm EVOL®SI Screw
• 00841193122724: 9.5mm x 025mm EVOL®SI Screw
• 00841193122717: 7.5mm x 060mm EVOL®SI Screw
• 00841193122700: 7.5mm x 055mm EVOL®SI Screw
• 00841193122694: 7.5mm x 050mm EVOL®SI Screw
• 00841193122687: 7.5mm x 045mm EVOL®SI Screw
• 00841193122670: 7.5mm x 040mm EVOL®SI Screw
• 00841193122663: 7.5mm x 035mm EVOL®SI Screw
• 00841193122656: EVOL®SI, Power Adapter, 1/4" Sq to Jacobs
• 00841193122649: EVOL®SI, Axial, Ratchet Handle, 1/4" Sq
• 00841193122632: EVOL®SI, T-Handle, Ratchet, 1/4" Sq
• 00841193122625: EVOL®SI, Radiolucent Wire Clamp
• 00841193122618: EVOL®SI, 2.4mm Temporary K-Wire
• 00841193122601: EVOL®SI, Bone Pusher
• 00841193122595: EVOL®SI, Bone Funnel
• 00841193122588: EVOL®SI, Insertion Sleeve (Large)
• 00841193122571: EVOL®SI, Down-biting, Serrated Curette
• 00841193122564: EVOL®SI, Up-biting, Serrated Curette
• 00841193122557: EVOL®SI, Screwdriver (T40 Solid)
• 00841193122540: EVOL®SI, Screwdriver (T40 Cannulated)
• 00841193122533: EVOL®SI, 11.5mm Cannulated Tap
• 00841193122526: EVOL®SI, 10.5mm Cannulated Tap
• 00841193122519: EVOL®SI, 9.5mm Cannulated Tap
• 00841193122502: EVOL®SI, 7.5mm Cannulated Tap