Arrowbone-A, Arrowbone-B
FDA 510(k) K083372 · Brainbase Corporation
510(k) numberK083372
Submission
- Device name
- Arrowbone-A, Arrowbone-B
- Applicant
- Brainbase Corporation
Bonita Springs, FL, US - Received
- November 14, 2008
- Decision date
- December 8, 2009
- 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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| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
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| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
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Questions and answers
When was Arrowbone-A, Arrowbone-B cleared by the FDA?
Arrowbone-A, Arrowbone-B (K083372) received a 510(k) decision of Substantially Equivalent on December 8, 2009, 389 days after the submission was received.
What is the product code of K083372?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.