Cem-Ostetic Cylinder CemO-DZ1040P

GUDID 00858418003843

Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, Cem-Ostetic resorbs and is later replaced by natural bone. Cem-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. Cem-Ostetic is an osteoconductive bone substitute shaped as blocks (cylinders) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The blocks (cylinders) may be pressed into the void or into the surgical site by hand. The Cem-Ostetic blocks (cylinders) provide void filling material that acts as a temporary support medium. The blocks (cylinders) are not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic

• Primary Device ID: 00858418003843
• NIH Device Record Key: 67ab045c-8f3f-4922-80cf-39b2701781e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cem-Ostetic Cylinder
• Version Model Number: CemO-DZ1040P
• Catalog Number: CemO-DZ1040P
• Company DUNS: 081067703
• Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC
• 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: true
• 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	00858418003843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030266

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-04-10

On-Brand Devices [Cem-Ostetic Cylinder]

• 00858418003843: Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
• 00858418003522: Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
• 00858418003515: Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan