CarriGen PF
510(k) K182107
CarriGen PF is a Class II device made by Etex Corporation, cleared under FDA 510(k) K182107 on 31 Aug 2018, 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 | NumberK182107 | Date31 Aug 2018 | StatusActive |
Official records
- FDA 510(k) database K182107
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- Withdrawn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 K182107
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 | |||
|---|---|---|---|---|
| AccuFill ® PreFill 206130 | 206130 / 206130 | 00889024501225 | Total Volume 3 mL | On the market |
| AccuFill ® PreFill 206150 | 206150 / 206150 | 00889024501232 | Total Volume 3 mL | On the market |
Similar devices
Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).
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- PRO OSTEON 500R by Ebi, L.P.
- GENEROS 80, GENEROS 60 by Berkeley Advanced Biomaterials
- NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE by NovaBone Products, LLC
- CALLOS IMPACT AND INJECT BONE VOID FILLER by SKELETAL KINETICS LLC
- BONESOURCE BVF by Howmedica Osteonics Corp.
- Montage-XT Settable, Resorbable Bone Putty by Orthocon, Inc.
- VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER by Orthovita, Inc.