Exactech Resorbable Room Temperature Bone Paste
510(k) K040755
Exactech Resorbable Room Temperature Bone Paste is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K040755 on 17 Jun 2004, 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 | NumberK040755 | Date17 Jun 2004 | StatusActive |
Official records
- FDA 510(k) database K040755
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- Withdrawn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 K040755
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 | |||
|---|---|---|---|---|
| OpteCure 650-00-01 | 650-00-01 / 650-00-01 | 10885862094780 | — | On the market |
| OpteCure 650-00-02 | 650-00-02 / 650-00-02 | 10885862094797 | — | No longer on the market |
| OpteCure 650-00-05 | 650-00-05 / 650-00-05 | 10885862094803 | — | On the market |
| OpteCure 650-00-10 | 650-00-10 / 650-00-10 | 10885862094810 | — | On the market |
| Optecure 650-00-20 | 650-00-20 / 650-00-20 | 10885862094827 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
- Wellgraft PE II by Gwowei Technology Co., Ltd.
- Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC by Isotis NV
- Actifuse Shape Bone Graft Substitute by Apatech Ltd
- Genex Putty by BIOCOMPOSITES LTD
- Bio2 CLM BG Bioactive Scaffold by BIO2 TECHNOLOGIES, INC.
- OsteoFlo HydroFiber by SURGENTEC LLC
- OSferion by Olympus Terumo Biomaterials Corporation
- COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X, 3X, 6X (1, 3 OR 6 STRIPS PER BOX) by Neucoll, Inc.
- AttraX Scaffold by Nu Vasive, Incorporated
- Calcigen PSI Bone Graft Substitute by Biomet Orthopedics, Inc.