MetaStep™ Calcaneus Locking Plate FH14008

GUDID 04048266131805

TiAl6V4 ELI non-sterile

Merete GmbH

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 04048266131805
• NIH Device Record Key: 5f344db3-207b-4e1d-9caf-f0d477d0e965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MetaStep™ Calcaneus Locking Plate
• Version Model Number: 8
• Catalog Number: FH14008
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266131805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120787

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

[04048266131805]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-05-05
• Device Publish Date: 2015-10-15

On-Brand Devices [MetaStep™ Calcaneus Locking Plate]

• 04048266131829: TiAl6V4 ELI non-sterile
• 04048266131812: TiAl6V4 ELI non-sterile
• 04048266131805: TiAl6V4 ELI non-sterile
• 04048266131799: TiAl6V4 ELI non-sterile
• 04048266131782: TiAl6V4 ELI non-sterile
• 04048266131775: TiAl6V4 ELI non-sterile
• 04048266131768: TiAl6V4 ELI non-sterile