487942

GUDID 10887587055657

TI MULTI-VECTOR DSTR PIN HLDG CLAMP/RAMUS-LIMITED BONE STOCK

SYNTHES (U.S.A.) LP

Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor

• Primary Device ID: 10887587055657
• NIH Device Record Key: f010f641-adff-46dc-8f89-9b1b2b3c6f0a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 487.942
• Catalog Number: 487942
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587055657 [Primary]
HIBCC	H9804879420 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010690

FDA Product Code

• DZL: SCREW, FIXATION, INTRAOSSEOUS

Sterilization

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

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

[10887587055657]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

• H981023060100 - NA: 2024-07-12 6.0MM PELVIC ROD-LEFT
• H981023060120 - NA: 2024-07-12 6.0MM PELVIC ROD-RIGHT
• H981042006140 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH
• H981042006150 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 30MM THREAD LENGTH
• H981042006160 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
• H981042006170 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
• H981042006180 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
• H981042006190 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH