Prodisc C SK

GUDID 00843193114020

Prodisc C SK, Extra Large Deep, 7mm

Centinel Spine, Inc.

Cervical total intervertebral disc prosthesis, modular

• Primary Device ID: 00843193114020
• NIH Device Record Key: 323d6f56-e11e-469b-8e60-818686e9b6d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodisc C SK
• Version Model Number: PDSXLD7
• Company DUNS: 949024850
• Company Name: Centinel Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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	00843193114020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P070001

FDA Product Code

• MJO: Prosthesis, Intervertebral Disc

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: 2023-07-27
• Device Publish Date: 2023-07-19

On-Brand Devices [Prodisc C SK]

• 00843193114020: Prodisc C SK, Extra Large Deep, 7mm
• 00843193114013: Prodisc C SK, Extra Large Deep, 6mm
• 00843193114006: Prodisc C SK, Extra Large Deep, 5mm
• 00843193113993: Prodisc C SK, Extra Large, 7mm
• 00843193113986: Prodisc C SK, Extra Large, 6mm
• 00843193113979: Prodisc C SK, Extra Large, 5mm
• 00843193113962: Prodisc C SK, Large Deep, 7mm
• 00843193113955: Prodisc C SK, Large Deep, 6mm
• 00843193113948: Prodisc C SK, Large Deep, 5mm
• 00843193113931: Prodisc C SK, Large, 7mm
• 00843193113924: Prodisc C SK, Large, 6mm
• 00843193113917: Prodisc C SK, Large, 5mm
• 00843193113900: Prodisc C SK, Medium Deep, 7mm
• 00843193113894: Prodisc C SK, Medium Deep, 6mm
• 00843193113887: Prodisc C SK, Medium Deep, 5mm
• 00843193113870: Prodisc C SK, Medium, 7mm
• 00843193113863: Prodisc C SK, Medium, 6mm
• 00843193113856: Prodisc C SK, Medium, 5mm