OIC Cannulated Screw System

GUDID M69607036P1

WASHER 7MM

ORTHOPAEDIC IMPLANT COMPANY, THE

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• Primary Device ID: M69607036P1
• NIH Device Record Key: 0db62408-c469-46e2-a723-6ac9a86c3a4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OIC Cannulated Screw System
• Version Model Number: 07-036P
• Company DUNS: 070061160
• Company Name: ORTHOPAEDIC IMPLANT COMPANY, THE
• Device Count: 6
• 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: 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: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com
• Phone: 775 636 8281
• Email: Info@OrthoImplantCompany.com

Device Dimensions

• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter
• Outer Diameter: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M69607036P0 [Unit of Use]
HIBCC	M69607036P1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113123

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

[M69607036P1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-02-01

On-Brand Devices [OIC Cannulated Screw System]

• 20811998035394: WASHER 7MM - TITANIUM
• 20811998032270: GUIDEPIN 2.5MM X 230MM
• 20811998030269: GUIDEPIN 2.8MM X 450MM
• 20811998030252: GUIDEPIN 2.8MM X 300MM
• 20811998030245: WASHER 13MM
• 20811998030238: GUIDEPIN 1.25MM X 150MM
• 20811998030221: WASHER 7MM
• M69601SHS160: LAG SCREW RETAINING ROD (FOR INSERTION)
• M69601SHS150: GUIDESHAFT W/FLATS
• M69601SHS010: LAG SCREW RETAINING ROD (FOR REMOVAL)
• 10811998032211: LAG SCREW RETAINING ROD (FOR INSERTION)
• 10811998032204: GUIDESHAFT W/FLATS
• 10811998032068: LAG SCREW RETAINING ROD (FOR REMOVAL)
• M69601SHS200: 130 DEG ANGLE GUIDE
• M69601SHS070: 145 DEG ANGLE GUIDE
• M69601SHS060: 140 DEG ANGLE GUIDE
• M69601SHS050: 135 DEG ANGLE GUIDE
• M69601SHS040: DRILL GUIDE 3.2MM/4.5MM (HIP SCREW)
• M6960173040: 2.8MM ADJ PIN GUIDE
• M6960140050: DRILL GUIDE 1.25MM/2.7MM DBL SIDED
• 10811998032259: 130 DEG ANGLE GUIDE
• 10811998032129: 145 DEG ANGLE GUIDE
• 10811998032112: 140 DEG ANGLE GUIDE
• 10811998032105: 135 DEG ANGLE GUIDE
• 10811998032099: DRILL GUIDE 3.2MM/4.5MM (HIP SCREW)
• 10811998030125: 2.8MM ADJ PIN GUIDE
• 10811998030064: DRILL GUIDE 1.25MM/2.7MM DBL SIDED
• M69601SHS190: TRIPLE REAMER LOCK NUT
• M69601SHS180: DEPTH GAUGE FOR SHS
• M69601SHS170: TRIPLE REAMER SHAFT
• M69601SHS090: STD REAMER HEAD
• M69601SHS080: SHORT REAMER HEAD
• M6960173110: SCREW FORCEPS
• 10811998032242: TRIPLE REAMER LOCK NUT
• 10811998032235: DEPTH GAUGE FOR SHS
• 10811998032228: TRIPLE REAMER SHAFT
• 10811998032143: STD REAMER HEAD
• 10811998032136: SHORT REAMER HEAD
• 10811998030194: SCREW FORCEPS
• 10811998039500: WASHER 7MM - TITANIUM (10 PACK)
• 10811998031566: 2.8MM X 450MM DRILL TIP GUIDEPIN (10 PACK)
• 10811998031559: 2.8MM X 300MM DRILL TIP GUIDEPIN (10 PACK)
• M6964001010: STERILIZATION CASE 4.0MM CANN SCREW CADDY
• M6964001000: STERILIZATION CASE 4.0MM CANN SCREW SET
• M6960401030: STERILIZATION CASE 4.0MM CANN SCREW SET
• M69601SHS0240: SHS SCREW CADDY
• M69601SHS0230: SHS IMPLANT CASE LID
• M69601SHS0220: SHS IMPLANT CASE
• M69601SHS0210: SHS INSTRUMENT CASE LID
• M69601SHS0200: SHS INSTRUMENT CASE