Home / 510(k) Clearances / K240133

510(k) K240133

Xenograft Bovine Bone Particulate by Collagen Solutions, LLC — Product Code NPM

K240133 is an FDA 510(k) premarket notification submitted by Collagen Solutions, LLC for the device "Xenograft Bovine Bone Particulate". The FDA issued a decision of Substantially Equivalent on August 16, 2024. The device falls under product code NPM (Bone Grafting Material, Animal Source), a Class II device regulated under 21 CFR 872.3930.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2024
Date Received
January 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Animal Source
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

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 clearances for product code NPM

  • K253723 — BOSS (June 16, 2026)
  • K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (July 11, 2025)
  • K251613 — SwissGraft X (June 26, 2025)
  • K242510 — Geistlich Bio-Flow® (March 7, 2025)
  • K230305 — THE Graft Collagen (July 24, 2024)
  • K240661 — Geistlich Bio-Oss® (July 12, 2024)
  • K231672 — S1 (October 13, 2023)
  • K221808 — InterOss Collagen (March 18, 2023)
  • K211551 — Wishbone HA (August 20, 2021)
  • K202183 — Porcine Mineral Collagen Composite (April 2, 2021)

FDA data resources