InterOss Collagen
FDA 510(k) K221808 · Sigmagraft, Inc.
510(k) numberK221808
Submission
- Device name
- InterOss Collagen
- Applicant
- Sigmagraft, Inc.
Fullerton, CA, US - Received
- June 22, 2022
- Decision date
- March 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NPM – Bone Grafting Material, Animal Source
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Other 510(k)s with product code NPM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253723 | BossNPM · Traditional | Medpark Co., Ltd. | 06/16/2026SE |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM · Special | Geistlich Pharma AG | 07/11/2025SE |
| K251613 | SwissGraft XNPM · Special | Geistlich Pharma AG | 06/26/2025SE |
| K242510 | Geistlich Bio-Flow®NPM · Traditional | Geistlich Pharma AG | 03/07/2025SE |
| K240133 | Xenograft Bovine Bone ParticulateNPM · Traditional | Collagen Solutions, LLC | 08/16/2024SE |
| K230305 | THE Graft CollagenNPM · Traditional | Purgo Biologics, Inc. | 07/24/2024SE |
| K240661 | Geistlich Bio-Oss®NPM · Traditional | Geistlich Pharma AG | 07/12/2024SE |
| K231672 | S1NPM · Traditional | Medpark Co., Ltd. | 10/13/2023SE |
| K211551 | Wishbone HANPM · Traditional | Wishbone SA | 08/20/2021SE |
| K202183 | Porcine Mineral Collagen CompositeNPM · Traditional | Collagen Matrix, Inc. | 04/02/2021SE |
More from Collagen Matrix, Inc.
Questions and answers
When was InterOss Collagen cleared by the FDA?
InterOss Collagen (K221808) received a 510(k) decision of Substantially Equivalent on March 18, 2023, 269 days after the submission was received.
What is the product code of K221808?
The FDA product code is NPM – Bone Grafting Material, Animal Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.