VOLT 04538513S

GUDID 10886982344861

3.5 VOLT(TM) PROX HUM PLATE LONG/13H/286MM/STERILE

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 10886982344861
• NIH Device Record Key: d11d090f-1a84-4517-a7aa-f834e5517317
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOLT
• Version Model Number: 04.538.513S
• Catalog Number: 04538513S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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(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	10886982344861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233994

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

[10886982344861]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [VOLT]

• 10886982317896: 2.0MM VOLT(TM) LOCKING SCREW 36MM T6 STERILE
• 10886982317889: 2.0MM VOLT(TM) LOCKING SCREW 36MM T6
• 10886982317872: 2.0MM VOLT(TM) LOCKING SCREW 34MM T6 STERILE
• 10886982317865: 2.0MM VOLT(TM) LOCKING SCREW 34MM T6
• 10886982317858: 2.0MM VOLT(TM) LOCKING SCREW 32MM T6 STERILE
• 10886982317841: 2.0MM VOLT(TM) LOCKING SCREW 32MM T6
• 10886982317834: 2.0MM VOLT(TM) LOCKING SCREW 30MM T6 STERILE
• 10886982317827: 2.0MM VOLT(TM) LOCKING SCREW 30MM T6
• 10886982317810: 2.0MM VOLT(TM) LOCKING SCREW 28MM T6 STERILE
• 10886982317803: 2.0MM VOLT(TM) LOCKING SCREW 28MM T6
• 10886982317797: 2.0MM VOLT(TM) LOCKING SCREW 26MM T6 STERILE
• 10886982317780: 2.0MM VOLT(TM) LOCKING SCREW 26MM T6
• 10886982317773: 2.0MM VOLT(TM) LOCKING SCREW 24MM T6 STERILE
• 10886982317766: 2.0MM VOLT(TM) LOCKING SCREW 24MM T6
• 10886982317759: 2.0MM VOLT(TM) LOCKING SCREW 22MM T6 STERILE
• 10886982317742: 2.0MM VOLT(TM) LOCKING SCREW 22MM T6
• 10886982317735: 2.0MM VOLT(TM) LOCKING SCREW 20MM T6 STERILE
• 10886982317728: 2.0MM VOLT(TM) LOCKING SCREW 20MM T6
• 10886982317711: 2.0MM VOLT(TM) LOCKING SCREW 19MM T6 STERILE
• 10886982317704: 2.0MM VOLT(TM) LOCKING SCREW 19MM T6
• 10886982317698: 2.0MM VOLT(TM) LOCKING SCREW 18MM T6 STERILE
• 10886982317681: 2.0MM VOLT(TM) LOCKING SCREW 18MM T6
• 10886982317674: 2.0MM VOLT(TM) LOCKING SCREW 17MM T6 STERILE
• 10886982317667: 2.0MM VOLT(TM) LOCKING SCREW 17MM T6
• 10886982317650: 2.0MM VOLT(TM) LOCKING SCREW 16MM T6 STERILE
• 10886982317643: 2.0MM VOLT(TM) LOCKING SCREW 16MM T6
• 10886982317636: 2.0MM VOLT(TM) LOCKING SCREW 15MM T6 STERILE
• 10886982317629: 2.0MM VOLT(TM) LOCKING SCREW 15MM T6
• 10886982317612: 2.0MM VOLT(TM) LOCKING SCREW 14MM T6 STERILE
• 10886982317605: 2.0MM VOLT(TM) LOCKING SCREW 14MM T6
• 10886982317599: 2.0MM VOLT(TM) LOCKING SCREW 13MM T6 STERILE
• 10886982317582: 2.0MM VOLT(TM) LOCKING SCREW 13MM T6
• 10886982317575: 2.0MM VOLT(TM) LOCKING SCREW 12MM T6 STERILE
• 10886982317568: 2.0MM VOLT(TM) LOCKING SCREW 12MM T6
• 10886982317551: 2.0MM VOLT(TM) LOCKING SCREW 11MM T6 STERILE
• 10886982317544: 2.0MM VOLT(TM) LOCKING SCREW 11MM T6
• 10886982317537: 2.0MM VOLT(TM) LOCKING SCREW 10MM T6 STERILE
• 10886982317520: 2.0MM VOLT(TM) LOCKING SCREW 10MM T6
• 10886982317513: 2.0MM VOLT(TM) LOCKING SCREW 9MM T6 STERILE
• 10886982317506: 2.0MM VOLT(TM) LOCKING SCREW 9MM T6
• 10886982317490: 2.0MM VOLT(TM) LOCKING SCREW 8MM T6 STERILE
• 10886982317483: 2.0MM VOLT(TM) LOCKING SCREW 8MM T6
• 10886982317476: 2.0MM VOLT(TM) LOCKING SCREW 7MM T6 STERILE
• 10886982317469: 2.0MM VOLT(TM) LOCKING SCREW 7MM T6
• 10886982317452: 2.0MM VOLT(TM) LOCKING SCREW 6MM T6 STERILE
• 10886982317445: 2.0MM VOLT(TM) LOCKING SCREW 6MM T6
• 10886982317438: 2.0MM VOLT(TM) CORTEX SCREW 50MM T6 STERILE
• 10886982317421: 2.0MM VOLT(TM) CORTEX SCREW 50MM T6
• 10886982317414: 2.0MM VOLT(TM) CORTEX SCREW 48MM T6 STERILE
• 10886982317407: 2.0MM VOLT(TM) CORTEX SCREW 48MM T6