OsteoFab Suture Anchor

GUDID 00850004435007

OsteoFab Suture Anchor Inserter

OXFORD PERFORMANCE MATERIALS, INC.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00850004435007
• NIH Device Record Key: d3e33732-3cfc-49ff-a630-4bf30bb2d03b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoFab Suture Anchor
• Version Model Number: INS002-02-001
• Company DUNS: 962301359
• Company Name: OXFORD PERFORMANCE MATERIALS, INC.
• 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: false
• 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: 1-860-698-9300
• Email: CustomerService@oxfordpm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004435007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190915

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00850004435007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-24
• Device Publish Date: 2020-01-16

On-Brand Devices [OsteoFab Suture Anchor]

• 00850004435069: OsteoFab 6.5mm Suture Anchor
• 00850004435052: OsteoFab 5.5mm Suture Anchor
• 00850004435045: OsteoFab 4.5mm Suture Anchor
• 00850004435038: 4mm OsteoFab Suture Anchor Awl
• 00850004435021: 3mm OsteoFab Suture Anchor Awl
• 00850004435014: 2mm OsteoFab Suture Anchor Awl
• 00850004435007: OsteoFab Suture Anchor Inserter