PK Shield

GUDID 00866453000123

PEEK Patient Specific Cranial Implant

Osteosymbionics, LLC

Cranioplasty plate, non-alterable

• Primary Device ID: 00866453000123
• NIH Device Record Key: 78cc6734-5f75-4779-b53e-e6143568c1eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PK Shield
• Version Model Number: IMP-PK
• Company DUNS: 858769651
• Company Name: Osteosymbionics, LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866453000123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121102

FDA Product Code

• GXN: Plate, Cranioplasty, Preformed, Non-Alterable

Sterilization

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

[00866453000123]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-26

Devices Manufactured by Osteosymbionics, LLC

• 00866453000109 - ClearShield (Non-Sterile): 2018-07-06 PMMA Patient Specific Cranial Implant (Non-Sterile)
• 00866453000123 - PK Shield: 2018-07-06PEEK Patient Specific Cranial Implant
• 00866453000123 - PK Shield: 2018-07-06 PEEK Patient Specific Cranial Implant
• 00866453000130 - ST Temporalis: 2018-07-06 Silicone Temporal Implant - Small
• 00866453000147 - ST Temporalis: 2018-07-06 Silicone Temporal Implant - Large
• 00866453000116 - ClearShield (Sterile): 2018-03-29 PMMA Patient Specific Cranial Implant (Sterile)