OsteoSeal Bone Hemostat
510(k) K142348
OsteoSeal Bone Hemostat is a device classified as Unclassified made by Hemostasis, LLC, cleared under FDA 510(k) K142348 on 23 Jan 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142348 | Date23 Jan 2015 | StatusActive |
Official records
- FDA 510(k) database K142348
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MTJ
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K142348
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BoneSeal 2.5 gram Ingot 9550054 | 9550054 | 00858439001538 | Weight 2.5 g | On the market |
| BoneSeal 2x2.5 gram Ingot 9550074 | 9550074 | 00858439001552 | Weight 5.0 g | No longer on the market |
| BoneSeal 3.5 gram Ingot 9550034 | 9550034 | 00858439001514 | Weight 3.5 g | On the market |
Similar devices
Other devices filed under FDA product code MTJ (Wax, Bone).
- CP MEDICAL BONE WAX by Cp Medical
- ROP Resorbable Hemostasis Material by Resorbable Orthopedic Products, LLC
- OSTENE CT, AOC CT, OSTEOTENE, CERETENE by Ceremed, Inc.
- AESCULAP BONE WAX by AESCULAP, INC.
- ORTHOSTAT by Orthocon, Inc.
- SHARPOINT LUKENS BONE WAX by Surgical Specialties Corp
- HEMASORBPLUS Resorbable Hemostatic Bone Putty by Orthocon, Inc.
- SKAFFOLD CIS by SKELETAL KINETICS LLC
- Bone Wax White 902 by Surgical Specialties México, S. de R.L. de C.V.
- AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE by Ceremed, Inc.