Merete® Cannulated HCS Headless Compression Screw CB04026S

GUDID 04048266154613

TiAl6V4 ELI sterile

Merete GmbH

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 04048266154613
• NIH Device Record Key: 1009e174-7e53-4396-97e0-becd969972c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merete® Cannulated HCS Headless Compression Screw
• Version Model Number: 4.3 26 T10
• Catalog Number: CB04026S
• Company DUNS: 313267265
• Company Name: Merete GmbH
• 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: true
• 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(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com

Device Dimensions

• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter
• Length: 26 Millimeter
• Outer Diameter: 4.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266154613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152187

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-07-24
• Device Publish Date: 2016-04-22

On-Brand Devices [Merete® Cannulated HCS Headless Compression Screw]

• 04048266154477: TiAl6V4 ELI sterile
• 04048266154545: TiAl6V4 ELI sterile
• 04048266154514: TiAl6V4 ELI sterile
• 04048266154484: TiAl6V4 ELI sterile
• 04048266154460: TiAl6V4 ELI sterile
• 04048266164971: 4.3 22 T10
• 04048266154736: 4.3 50 T10
• 04048266154682: 4.3 40 T10
• 04048266154552: 3.0 32 T10
• 04048266154538: 3.0 28 T10
• 04048266154507: 3.0 22 T10
• 04048266053947: 6.5 120 Hex3.5
• 04048266053930: 6.5 115 Hex3.5
• 04048266053923: 6.5 110 Hex3.5
• 04048266053916: 6.5 105 Hex3.5
• 04048266053909: 6.5 100 Hex3.5
• 04048266053893: 6.5 95 Hex3.5
• 04048266053886: 6.5 90 Hex3.5
• 04048266053879: 6.5 85 Hex3.5
• 04048266053862: 6.5 80 Hex3.5
• 04048266053855: 6.5 75 Hex3.5
• 04048266053848: 6.5 70 Hex3.5
• 04048266053831: 6.5 65 Hex3.5
• 04048266053824: 6.5 60 Hex3.5
• 04048266053817: 6.5 55 Hex3.5
• 04048266053800: 6.5 50 Hex3.5
• 04048266053794: 6.5 45 Hex3.5
• 04048266053787: 6.5 40 Hex3.5
• 04048266053770: 4.3 60 Hex2.5
• 04048266053763: 4.3 55 Hex2.5
• 04048266053756: 4.3 50 Hex2.5
• 04048266053749: 4.3 48 Hex2.5
• 04048266053732: 4.3 46 Hex2.5
• 04048266053725: 4.3 44 Hex2.5
• 04048266053718: 4.3 42 Hex2.5
• 04048266053701: 4.3 40 Hex2.5
• 04048266053695: 4.3 38 Hex2.5
• 04048266053688: 4.3 36 Hex2.5
• 04048266053671: 4.3 34 Hex2.5
• 04048266053664: 4.3 32 Hex2.5
• 04048266053657: 4.3 30 Hex2.5
• 04048266053640: 4.3 28 Hex2.5
• 04048266053633: 4.3 26 Hex2.5
• 04048266053626: 4.3 24 Hex2.5
• 04048266053619: 4.3 22 Hex2.5
• 04048266053602: 4.3 20 Hex2.5
• 04048266053596: 3.0 40 Hex2.5
• 04048266053589: 3.0 35 Hex2.5
• 04048266053572: 3.0 32 Hex2.5
• 04048266053565: 3.0 30 Hex2.5