Search Results

The Bicon Bone Graft Screws are indicated for those cases where a clinician intends to attact has The Dicon Done Graft Delevis are mercase of augmenting and replacing bone that has been lost.

Bone Graft Screw System

I am sorry, but the provided text from the FDA 510(k) letter for the "Bone Graft Screw System" does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

The letter is a notification of substantial equivalence for a medical device submitted on November 12, 1997. It primarily focuses on the regulatory approval and classification of the device based on its substantial equivalence to previously marketed devices. The key information it provides is:

• Device Name: Bone Graft Screw System
• Trade Name: (Not explicitly stated in the provided text, but likely related to Bicon Dental Implants, the submitter).
• Regulatory Class: II
• Product Code: DZL
• Indications for Use: "The Bicon Bone Graft Screws are indicated for those cases where a clinician intends to attach bone grafts in the process of augmenting and replacing bone that has been lost."
• Submitter: Vincent J. Morgan, D.M.D., President, Bicon Dental Implants.
• Date of Submission: August 12, 1997
• Date of Receipt: August 15, 1997
• FDA Decision: Substantially Equivalent, allowing marketing under general controls provisions.

To answer your request, a detailed performance study with acceptance criteria would typically be found in the 510(k) summary or the full 510(k) submission, neither of which is included in the provided text. The letter only refers to "indications for use stated in the enclosure," and then that enclosure states the generic indication for bone graft screws.

Therefore, I cannot provide the requested table and study details based on the given input.

Ask a specific question about this device