Dynamik Intervertebral Body Fusion Device DYN-BS 22 10-S

GUDID 07640139342294

Bone Substitute L22 H10

SpineArt SA

Bone matrix implant, synthetic

• Primary Device ID: 07640139342294
• NIH Device Record Key: 291117dd-bc17-4ca5-8223-d5c814d98985
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynamik Intervertebral Body Fusion Device
• Version Model Number: DYN-BS 22 10-S
• Catalog Number: DYN-BS 22 10-S
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: 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 Dimensions

• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter
• Height: 10 Millimeter
• Length: 22 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640139342294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081888

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

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: 2018-04-12
• Device Publish Date: 2018-03-12

On-Brand Devices [Dynamik Intervertebral Body Fusion Device ]

• 07640139343819: Bone Substitute L22 H16
• 07640139342812: Curved Transforaminal Lumbar Cage
• 07640139342805: Curved Transforaminal Lumbar Cage
• 07640139342799: Curved Transforaminal Lumbar Cage
• 07640139342782: Curved Transforaminal Lumbar Cage
• 07640139342584: ANTERIOR LUMBAR PEEK CAGE
• 07640139342577: ANTERIOR LUMBAR PEEK CAGE
• 07640139342560: ANTERIOR LUMBAR PEEK CAGE
• 07640139342553: ANTERIOR LUMBAR PEEK CAGE
• 07640139342546: ANTERIOR LUMBAR PEEK CAGE
• 07640139342539: ANTERIOR LUMBAR PEEK CAGE
• 07640139342522: ANTERIOR LUMBAR PEEK CAGE
• 07640139342515: ANTERIOR LUMBAR PEEK CAGE
• 07640139342317: Bone Substitute L22 H14
• 07640139342300: Bone Substitute L22 H12
• 07640139342294: Bone Substitute L22 H10
• 07640139342287: Bone Substitute L22 H08
• 07640139342270: Lumbar Posterior Cage
• 07640139342263: Lumbar Posterior Cage
• 07640139342256: Lumbar Posterior Cage
• 07640139342249: Lumbar Posterior Cage
• 07640139342232: Lumbar Posterior Cage
• 07640139342225: Lumbar Posterior Cage
• 07640139342218: Lumbar Posterior Cage
• 07640139342201: Lumbar Posterior Cage
• 07640178985650: GRAFT FUNNEL PLUNGER 5MM