EARP Interbody System

GUDID 00810135960007

EARP, 14X25X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00810135960007
• NIH Device Record Key: c35a3eb3-bd7f-41f8-9c57-78fbffb7c234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EARP Interbody System
• Version Model Number: EARP1425-0008
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, 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: 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: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com
• Phone: 210-598-5641
• Email: diana@nvisionbiomed.com

Device Dimensions

• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter
• Depth: 14 Millimeter
• Width: 25 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810135960007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212477

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

[00810135960007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-02
• Device Publish Date: 2023-10-25

Devices Manufactured by NVISION BIOMEDICAL TECHNOLOGIES, INC.

• 00810005665179 - Boundary: 2024-08-16 Buttress Plate Screw 20mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665186 - Boundary: 2024-08-16 Buttress Plate Screw 25mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665193 - Boundary: 2024-08-16 Buttress Plate Screw 30mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665209 - Boundary: 2024-08-16 Buttress Plate Screw 35mm long, 5.5mm circumference, non locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is in
• 00810005665216 - Boundary: 2024-08-16 Buttress Plate Screw 20mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend
• 00810005665223 - Boundary: 2024-08-16 Buttress Plate Screw 30mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend
• 00810005665230 - Boundary: 2024-08-16 Buttress Plate Screw 25mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend
• 00810005665247 - Boundary: 2024-08-16 Buttress Plate Screw 35mm long, 5.5mm circumference, locking, cancellous. The Boundary Anterior Lumbar Buttress Plate is intend