Quattro®

GUDID 00887868270406

Quattro® Bolt Tenodesis Screw (7mm x 14mm)

CAYENNE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00887868270406
• NIH Device Record Key: fe11636e-d363-4179-aace-ef22f912c33a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quattro®
• Version Model Number: CM-9507
• Company DUNS: 606719685
• Company Name: CAYENNE MEDICAL, INC.
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868270406 [Primary]
HIBCC	M543CM9507 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143392

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [Quattro®]

• M543CM9580: CM-9580
• M543CM9570: CM-9570
• M543CM9560: CM-9560
• M543CM9550: CM-9550
• M543CM9540: CM-9540
• M543CM9500: CM-9500
• M543CM9303: CM-9303
• M543CM9302: CM-9302
• M543CM9301: CM-9301
• M543CM9203: CM-9203
• M543CM9202: CM-9202
• M543CM9201: CM-9201
• M543CM9200: CM-9200
• M543CM9148: CM-9148
• M543CM9138: CM-9138
• M543CM9130: CM-9130
• M543CM9100: CM-9100
• M543CM9016: CM-9016
• M543CM9015: CM-9015
• M543CM9014: CM-9014
• M543CM9013: CM-9013
• M543CM9012: CM-9012
• M543CM9011: CM-9011
• M543CM9010: CM-9010
• M543CM9009: CM-9009
• M543CM9008: CM-9008
• M543CM9007: CM-9007
• M543CM9006: CM-9006
• M543CM9005: CM-9005
• M543CM9004: CM-9004
• M543CM9003: CM-9003
• M543CM9002: CM-9002
• M543CM9001: CM-9001
• M543CM8010: CM-8010
• M543CM9010LS1: CM-9010LS
• M543CM9010GTS1: CM-9010GTS
• M543CM9010GT1: CM-9010GT
• M543CM9324ST1: CM-9324ST
• M543CM9300ST1: CM-9300ST
• 00887868270970: CM-9265BGS
• 00887868270963: CM-9265BG
• 00887868270956: CM-9255BGS
• 00887868270949: CM-9255BG
• 00887868270475: CM-9580
• 00887868270468: CM-9570
• 00887868270451: CM-9560
• 00887868270444: CM-9550
• 00887868270437: CM-9540
• 00887868270420: Quattro® Bolt Tenodesis Screw (9mm x 16mm)
• 00887868270413: Quattro® Bolt Tenodesis Screw (8mm x 16mm)