Dual Anchor Inserter Multi-Pack TR-0001-D3

GUDID 10810063820159

Multi-Pack

Embody, Inc.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10810063820159
• NIH Device Record Key: c90af209-a1b0-4de4-a288-95c0a684802d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Anchor Inserter Multi-Pack
• Version Model Number: TR-0001-D3
• Catalog Number: TR-0001-D3
• Company DUNS: 079544913
• Company Name: Embody, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810063820159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213958

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-16
• Device Publish Date: 2022-11-08

Devices Manufactured by Embody, Inc.

• 00810063820473 - TAPESTRY Biointegrative Implant with Introducer, w/ Cannula: 2024-02-19
• 00810063820480 - TAPESTRY Biointegrative Implant with Introducer, w/ Cannula: 2024-02-19
• 00810063820510 - TAPESTRY RC Biointegrative Implant System: 2024-02-19 Disposable kit
• 00810063820527 - TAPESTRY RC Biointegrative Implant System: 2024-02-19 Disposable kit
• 00810063820497 - TAPESTRY RC Biointegrative Implant System: 2023-10-11 Disposable kit
• 00810063820503 - TAPESTRY RC Biointegrative Implant System: 2023-10-11 Disposable kit
• 00810063820459 - TAPESTRY Biointegrative Implant with Introducer: 2023-09-29 TAPESTRY Biointegrative Implant with Introducer, Anterior, 26mm x 26mm
• 00810063820466 - TAPESTRY Biointegrative Implant with Introducer: 2023-09-29 TAPESTRY Biointegrative Implant with Introducer, Lateral, 26mm x 26mm