456313S

GUDID H679456313S0

TI END CAP FOR TROCHANTERIC FIXATION NAILS 10MM EXT-STER

SYNTHES (U.S.A.) LP

Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap Bone nail end-cap

• Primary Device ID: H679456313S0
• NIH Device Record Key: 8f42793b-8655-4abf-ba6b-6ed37c855d5e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 456.313S
• Catalog Number: 456313S
• 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: 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
• 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	10886982226884 [Primary]
HIBCC	H679456313S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011857

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

[H679456313S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-04-07
• Device Publish Date: 2015-09-14

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

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• 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