04651300

GUDID H981046513000

5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/100MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H981046513000
• NIH Device Record Key: cd99fabd-4e29-4953-bf74-eb16fc4744f4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.651.300
• Catalog Number: 04651300
• Company DUNS: 486711679
• Company Name: Synthes 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: 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
• 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	10705034751757 [Primary]
HIBCC	H981046513000 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093668

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

[H981046513000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-26
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982313690 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
• 10886982313706 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
• 10886982313713 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
• 10886982313720 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE
• 10886982313737 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM
• 10886982313744 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 3H/93MM/STERILE
• 10886982313751 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM
• 10886982313768 - VOLT: 2025-04-03 3.5 VOLT(TM) PROX HUM PLATE 5H/119MM/STERILE