MD-Vue™ Lateral Discectomy System 60-BK-7001

GUDID 00840019967358

Implant Caddy - 18mm x 15° Kit

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840019967358
• NIH Device Record Key: 767eb82a-d92d-4858-a939-9a74775d4c69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD-Vue™ Lateral Discectomy System
• Version Model Number: 60-BK-7001
• Catalog Number: 60-BK-7001
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019967358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

[00840019967358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [MD-Vue™ Lateral Discectomy System]

• 00840019966924: Angled Trial 18 X 08mm 0°
• 00840019967310: Trial 24 x 18 mm 15°
• 00840019967303: Angled Trial 24 X 16mm 0°
• 00840019967297: Trial 24 x 16 mm 15°
• 00840019967280: Trial 24 x 16 mm 0°
• 00840019967273: Trial 24 x 16 mm 7°
• 00840019967266: Angled Trial 24 X 14mm 0°
• 00840019967259: Trial 24 x 14 mm 15°
• 00840019967242: Trial 24 x 14 mm 0°
• 00840019967235: Trial 24 x 14 mm 7°
• 00840019967228: Angled Trial 24 X 12mm 0°
• 00840019967211: Trial 24 x 12 mm 15°
• 00840019967204: Trial 24 x 12 mm 0°
• 00840019967198: Trial 24 x 12 mm 7°
• 00840019967181: Angled Trial 24 X 10mm 0°
• 00840019967174: Trial 24 x 10 mm 15°
• 00840019967167: Trial 24 x 10 mm 0°
• 00840019967150: Trial 24 x 10 mm 7°
• 00840019967143: Angled Trial 24 X 08mm 0°
• 00840019967136: Trial 24 x 08 mm 0°
• 00840019967129: Trial 24 x 08 mm 7°
• 00840019967112: Trial 22 x 18 mm 15°
• 00840019967105: Angled Trial 22 X 16mm 0°
• 00840019967099: Trial 22 x 16 mm 15°
• 00840019967082: Angled Trial 22 X 14mm 0°
• 00840019967075: Trial 22 x 14 mm 15°
• 00840019967068: Angled Trial 22 X 12mm 0°
• 00840019967051: Trial 22 x 12 mm 15°
• 00840019967044: Angled Trial 22 X 10mm 0°
• 00840019967037: Trial 22 x 10 mm 15°
• 00840019967020: Angled Trial 22 X 08mm 0°
• 00840019967013: Trial 18 x 18 mm 15°
• 00840019967006: Angled Trial 18 X 16mm 0°
• 00840019966993: Trial 18 x 16 mm 15°
• 00840019966986: Angled Trial 18 X 14mm 0°
• 00840019966979: Trial 18 x 14 mm 15°
• 00840019966962: Angled Trial 18 X 12mm 0°
• 00840019966955: Trial 18 x 12 mm 15°
• 00840019966948: Angled Trial 18 X 10mm 0°
• 00840019966931: Trial 18 x 10 mm 15°
• 00840019967334: Implant Caddy - 24mm x 7° Kit
• 00840019967327: Implant Caddy - 24mm x 7° (Empty)
• 00840019967433: 15° Implant Kit - 18mm & 22mm Widths
• 00840019967426: Implant Caddy - 24mm x 15° w/ 18mm H Kit
• 00840019967419: Implant Caddy - 24mm x 15° Kit
• 00840019967402: Implant Caddy - 24mm x 15° (Empty)
• 00840019967396: Implant Caddy - 22mm x 15° w/ 18mm H Kit
• 00840019967389: Implant Caddy - 22mm x 15° Kit
• 00840019967372: Implant Caddy - 22mm x 15° (Empty)
• 00840019967365: Implant Caddy - 18mm x 15° w/ 18mm H Kit