SD498134

GUDID H981SD4981340

3.5MM TI CURVED ROD 60MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H981SD4981340
• NIH Device Record Key: 6efb3ea3-c919-421e-80ec-cedc6dd377ca
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD498.134
• Catalog Number: SD498134
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034710006 [Primary]
HIBCC	H981SD4981340 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091689

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

Moist Heat or Steam Sterilization

[H981SD4981340]

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

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• 10887587078359 - NA: 2024-04-16 MANDIBLE BODY REDUCTION HANDLE
• 10886982344427 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/TIBIAL FIXTN/LNG/STER
• 10886982344434 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/TIBIAL FIXTN/LNG/STER
• 10886982345745 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-11MM RIGID/LONG/STERILE
• 10886982345752 - NA: 2024-03-21 PROTECTION SLV F/NAILS/Ø8-13MM RIGID/LONG/STERILE
• H67904038070S0 - TFN-ADVANCE: 2024-02-27 TFNA SCREW 70MM - STERILE