MONARCH 177091080

GUDID 10705034059808

MONARCH SPINE SYSTEM WASHER, POLYAXIAL

DEPUY SPINE, LLC

Implantable bone washer

• Primary Device ID: 10705034059808
• NIH Device Record Key: d88ba5b0-619a-44ec-a7f1-b0dd4b6d4339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONARCH
• Version Model Number: 177091080
• Catalog Number: 177091080
• Company DUNS: 107105876
• Company Name: DEPUY 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: false
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034059808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024348

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

[10705034059808]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

On-Brand Devices [MONARCH]

• 10705034059853: MONARCH SPINE SYSTEM DUAL CONNECTOR, CLOSED, SIDE, 6.35 X 4.75mm
• 10705034197104: MONARCH SPINE SYSTEM REDUCTION INSTRUMENT
• 10705034196923: MONARCH SPINE SYSTEM DISTRACTOR 5.5mm
• 10705034196916: MONARCH SPINE SYSTEM DISTRACTOR 6.35mm
• 10705034196886: MONARCH SPINE SYSTEM CAP INSERTER, SHORT
• 10705034196879: MONARCH SPINE SYSTEM CAP INSERTER
• 10705034196701: MONARCH SPINE SYSTEM WASHER,INSERTER,SPACER
• 10705034196633: MONARCH SPINE SYSTEM RATCHETING ROD CLAMP 6.35mm
• 10705034196374: MONARCH SPINE SYSTEM MODULAR SPHERICAL HANDLE
• 10705034301099: MONARCH SPINE SYSTEM HOOK HOLDER
• 10705034197159: MONARCH SPINE SYSTEM HOOK HOLDER,CLOSED,STRAIGHT
• 10705034197128: MONARCH SPINE SYSTEM OPEN HOOK HOLDER,OFFSET
• 10705034197111: MONARCH SPINE SYSTEM OPEN HOOK HOLDER,OFFSET
• 10705034197036: MONARCH SPINE SYSTEM SCREW ALIGNMENT GUIDE
• 10705034196619: MONARCH SPINE SYSTEM ROD HOLDER
• 10705034196602: MONARCH SPINE SYSTEM ROD HOLDER
• 10705034196596: MONARCH SPINE SYSTEM STRAIGHT FORCEP ROD HOLDER 6.35mm
• 10705034301181: MONARCH SPINE SYSTEM SCREW CADDY 5.5mm
• 10705034198071: MONARCH SPINE SYSTEM HOOK CASE
• 10705034198064: MONARCH SPINE SYSTEM INSTRUMENT TRAY
• 10705034198057: MONARCH SPINE SYSTEM INSTRUMENT TRAY
• 10705034198040: MONARCH SPINE SYSTEM INSTRUMENT CASE
• 10705034198033: MONARCH SPINE SYSTEM SCREW CADDY 8.5mm
• 10705034198026: MONARCH SPINE SYSTEM SCREW CADDY 7.75mm
• 10705034198019: MONARCH SPINE SYSTEM SCREW CADDY 7mm
• 10705034198002: MONARCH SPINE SYSTEM SCREW CADDY 6.25mm
• 10705034197999: MONARCH SPINE SYSTEM SCREW CADDY 4.75mm
• 10705034197982: MONARCH SPINE SYSTEM SCREW TRAY
• 10705034197975: MONARCH SPINE SYSTEM SLOTTED CONNECTOR CADDIE
• 10705034197968: MONARCH SPINE SYSTEM CADDY 6.35
• 10705034197951: MONARCH SPINE SYSTEM MCC CADDIE 5.50mm
• 10705034197944: MONARCH SPINE SYSTEM IMPLANT CASE
• 10705034197548: MONARCH SPINE SYSTEM HOOK CASE
• 10705034197531: MONARCH SPINE SYSTEM SCREW CADDY 7.75mm / 8.5mm
• 10705034197517: MONARCH SPINE SYSTEM POLY SCREW INSTRUMENT TRAY
• 10705034197500: MONARCH SPINE SYSTEM N/C/STD SCREW INSTRUMENT TRAY
• 10705034197470: MONARCH SPINE SYSTEM LOW BACK CORE INSTRUMENT CASE
• 10705034197463: MONARCH SPINE SYSTEM SCREW CADDY 7mm
• 10705034197456: MONARCH SPINE SYSTEM SCREW CADDY 6.25mm
• 10705034197449: MONARCH SPINE SYSTEM SCREW CADDY 5.5mm
• 10705034197432: MONARCH SPINE SYSTEM SCREW CADDY 4.75mm
• 10705034197425: MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 8.50mm
• 10705034197418: MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 7.75mm
• 10705034197401: MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 7.0mm
• 10705034197395: MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 6.25mm
• 10705034197388: MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 5.50mm
• 10705034197371: MONARCH SPINE SYSTEM POLYAXIAL SCREW CADDIE 4.75mm
• 10705034197364: MONARCH SPINE SYSTEM POLYAXIAL/HOOK CAP CADDIE
• 10705034197357: MONARCH SPINE SYSTEM STANDARD SCREW CADDIE 8.50mm
• 10705034197340: MONARCH SPINE SYSTEM STANDARD SCREW CADDIE 7.75mm