OsteoCentric 4.0 x 80mm LOCKING BONE SCREW FASTENER ST 340-6080

GUDID 00816950027659

4.0 x 80mm LOCKING BONE SCREW FASTENER, ST

SMV SCIENTIFIC LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00816950027659
• NIH Device Record Key: c3548bbd-a73b-44c9-9037-61a866ffd2b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoCentric 4.0 x 80mm LOCKING BONE SCREW FASTENER ST
• Version Model Number: 340-6080
• Catalog Number: 340-6080
• Company DUNS: 089645059
• Company Name: SMV SCIENTIFIC LLC
• 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: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: gudid@smvscientific.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Dimensions

• Length: 80 Millimeter
• Length: 80 Millimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950027659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190430

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00816950027659]

Moist Heat or Steam Sterilization

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[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

[00816950027659]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

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• 00810074300056 - 4.0 x 22mm Screw Super Fastener, ST: 2023-06-20 4.0 x 22mm Screw Super Fastener, ST
• 00810074300063 - 4.0 x 24mm Screw Super Fastener, ST: 2023-06-20 4.0 x 24mm Screw Super Fastener, ST
• 00810074300070 - 4.0 x 26mm Screw Super Fastener, ST: 2023-06-20 4.0 x 26mm Screw Super Fastener, ST