Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler
FDA 510(k) K010701 · Medtronic Sofamor Danek USA, Inc.
510(k) numberK010701
Submission
- Device name
- Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler
- Applicant
- Medtronic Sofamor Danek USA, Inc.
Memphis, TN, US - Received
- March 8, 2001
- Decision date
- June 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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Questions and answers
When was Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler cleared by the FDA?
Medtronic Sofamor Danek Biphasic Calcium Phosphate (BCP) Bone Void Filler (K010701) received a 510(k) decision of Substantially Equivalent on June 5, 2001, 89 days after the submission was received.
What is the product code of K010701?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.