Ossipro Bone Substitute Material
by Etex Corp.
510(k) K062630
Ossipro Bone Substitute Material is a Class II device made by Etex Corp., cleared under FDA 510(k) K062630 on 28 Jun 2007, 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 | NumberK062630 | Date28 Jun 2007 | StatusActive |
Official records
- FDA 510(k) database K062630
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQV
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3045
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K062630
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 | |||
|---|---|---|---|---|
| N-Force Blue IN050-5 | IN050-5 / IN050-5 | 00889024563261 | — | On the market |
| N-Force Blue IN050-6 | IN050-6 / IN050-6 | 00889024563254 | — | On the market |
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
- SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) by Synthes (Usa)
- OSTEO-LINK BONE VOID FILLER PELLETS by Promed Advance Technology Co., Ltd.
- TRI-OSTETIC by Berkeley Advanced Biomaterials
- Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ by BONE SOLUTIONS, INC.
- OSTEOCURE RESORBABLE BEAD KIT by Nexa Orthopedics, Inc.
- BSM BONE SUBSTITUTE MATERIAL by DEPUY ORTHOPAEDICS, INC.
- NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT by NovaBone Products, LLC
- A-GRIX RESORBABLE BONE VOID FILLER by Ag Digital Technology Corp.
- Mg OSTEOINJECT by BONE SOLUTIONS, INC.
- GaiaBone Bioabsorbable Bone Graft by Corliber (Shenzhen) Medical Device Co., Ltd.