03312840

GUDID H679033128400

MAXFRAME(TM) RADIOGRAPHIC MARKER

Synthes GmbH

External orthopaedic fixation system, reusable

• Primary Device ID: H679033128400
• NIH Device Record Key: ef4379dd-9fe1-4d05-ab17-0c947445c7c6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.312.840
• Catalog Number: 03312840
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982260956 [Primary]
HIBCC	H679033128400 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161417

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

[H679033128400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-02
• Device Publish Date: 2017-04-19

Devices Manufactured by Synthes GmbH

• 10887587078434 - NA: 2025-07-03 REDUCTION FORCEPS W/ POINTS
• 10886982343994 - NA: 2025-07-01 Ø14MM HOLLOW REAMER - FRN
• 07611819642669 - NA: 2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 07611819642676 - NA: 2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 07611819655522 - NA: 2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
• 10886982348159 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER
• 10886982348166 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER
• 10886982348173 - NA: 2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/175MM/HA STER