SD04600018

GUDID H981SD046000180

6.0MM TI PRECONTOURED ROD 80MM STRAIGHT LENGTH/500MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H981SD046000180
• NIH Device Record Key: eb73195e-410f-4720-b46e-87a9c46ea22e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD04.600.018
• Catalog Number: SD04600018
• 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	10705034705262 [Primary]
HIBCC	H981SD046000180 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031175

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

Moist Heat or Steam Sterilization

[H981SD046000180]

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

• 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