Carrigen
510(k) K093447
Carrigen is a Class II device made by Etex Corp., cleared under FDA 510(k) K093447 on 18 Feb 2010, 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 | NumberK093447 | Date18 Feb 2010 | StatusActive |
Official records
- FDA 510(k) database K093447
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- Withdrawn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 K093447
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 IN050-1 | IN050-1 | 00889024430075 | Total Volume 10 mL | On the market |
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
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- GranOSTM - beta tricalcium phosphate synthetic bone granules by Tcm Associates, Ltd.
- NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT by Pioneer Surgical Technology, Inc.
- Pioneer Surgical Nanoss BVF-E by Pioneer Surgical Technology, Inc.
- CureOs TCP by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic
- Eovia Calcium Phosphate Ceramic by Ortho Tec, LLC