HA Coated S-Core Implant

GUDID 10850017962191

HA Coated 9 mm x 9.5 mm S-Core Implant

SUBCHONDRAL SOLUTIONS, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 10850017962191
• NIH Device Record Key: 206b687e-19e6-4f1d-809e-7b1e5174f4e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HA Coated S-Core Implant
• Version Model Number: 20-0900-01-P
• Company DUNS: 117417828
• Company Name: SUBCHONDRAL SOLUTIONS, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter
• Height: 9 Millimeter
• Length: 9.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017962194 [Primary]
GS1	10850017962191 [Package]; Contains: 00850017962194; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191995

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2020-10-30
• Device Publish Date: 2020-10-22

On-Brand Devices [HA Coated S-Core Implant]

• 10850017962207: HA Coated 10 mm x 10 mm S-Core Implant
• 10850017962191: HA Coated 9 mm x 9.5 mm S-Core Implant
• 10850017962184: HA Coated 8 mm x 9 mm S-Core Implant
• 10850017962177: HA Coated 7 mm x 8.5 mm S-Core Implant
• 10850017962160: HA Coated 6 mm x 8 mm S-Core Implant
• 10850017962153: HA Coated 5 mm x 7.5 mm S-Core Implant
• 10850017962146: HA Coated 4 mm x 7 mm S-Core Implant