COLOSSEUM Mesh
510(k) K190147
COLOSSEUM Mesh is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K190147 on 8 May 2019, 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 | NumberK190147 | Date8 May 2019 | StatusActive |
Official records
- FDA 510(k) database K190147
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K190147
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 | |||
|---|---|---|---|---|
| COLOSSEUM 156.202 | 156.202 | 00889095975666 | Width 14 mm; Depth 12 mm; Height 8 mm | On the market |
| COLOSSEUM 156.205 | 156.205 | 00889095975697 | Height 20 mm; Width 14 mm; Depth 12 mm | On the market |
| COLOSSEUM 156.206 | 156.206 | 00889095975703 | Width 14 mm; Depth 12 mm; Height 24 mm | On the market |
| COLOSSEUM 156.207 | 156.207 | 00889095975710 | Depth 12 mm; Width 14 mm; Height 28 mm | On the market |
| COLOSSEUM 156.220 | 156.220 | 00889095975789 | Height 80 mm; Width 14 mm; Depth 12 mm | On the market |
| COLOSSEUM 156.232 | 156.232 | 00889095975857 | Width 14 mm; Depth 12 mm; Height 48 mm | On the market |
| COLOSSEUM 156.236 | 156.236 | 00889095975871 | Depth 12 mm; Height 64 mm; Width 14 mm | On the market |
| COLOSSEUM 156.240 | 156.240 | 00889095975895 | Height 80 mm; Depth 12 mm; Width 14 mm | On the market |
| COLOSSEUM 156.253 | 156.253 | 00889095975925 | Width 14 mm; Height 3 mm; Depth 12 mm | On the market |
| COLOSSEUM 156.262 | 156.262 | 00889095975963 | Height 2 mm; Depth 12 mm; Angle 3.5 deg; Width 14 mm | On the market |
| COLOSSEUM 156.264 | 156.264 | 00889095975987 | Height 4 mm; Angle 3.5 deg; Width 14 mm; Depth 12 mm | On the market |
| COLOSSEUM 156.266 | 156.266 | 00889095975994 | Width 14 mm; Angle 3.5 deg; Depth 12 mm; Height 6 mm | On the market |
| COLOSSEUM 156.273 | 156.273 | 00889095976007 | Angle 7 deg; Width 14 mm; Depth 12 mm; Height 3 mm | On the market |
| COLOSSEUM 156.276 | 156.276 | 00889095976038 | Width 14 mm; Angle 7 deg; Height 7 mm; Depth 12 mm | On the market |
| COLOSSEUM 156.302 | 156.302 | 00889095976045 | Depth 16 mm; Height 8 mm; Width 16 mm | On the market |
| COLOSSEUM 156.306 | 156.306 | 00889095976083 | Depth 16 mm; Width 16 mm; Height 24 mm | On the market |
| COLOSSEUM 156.309 | 156.309 | 00889095976113 | Height 36 mm; Depth 16 mm; Width 16 mm | On the market |
| COLOSSEUM 156.310 | 156.310 | 00889095976120 | Depth 16 mm; Height 40 mm; Width 16 mm | On the market |
| COLOSSEUM 156.311 | 156.311 | 00889095976137 | Height 44 mm; Width 16 mm; Depth 16 mm | On the market |
| COLOSSEUM 156.312 | 156.312 | 00889095976144 | Depth 16 mm; Height 48 mm; Width 16 mm | On the market |
| COLOSSEUM 156.337 | 156.337 | 00889095976182 | Depth 16 mm; Height 148 mm; Width 16 mm | On the market |
| COLOSSEUM 156.356 | 156.356 | 00889095976212 | Width 16 mm; Depth 16 mm; Height 6 mm | On the market |
| COLOSSEUM 156.406 | 156.406 | 00889095976328 | Height 24 mm; Width 18 mm; Depth 15 mm | On the market |
| COLOSSEUM 156.408 | 156.408 | 00889095976342 | Depth 15 mm; Width 18 mm; Height 32 mm | On the market |
| COLOSSEUM 156.437 | 156.437 | 00889095976427 | Width 18 mm; Height 148 mm; Depth 15 mm | On the market |
| COLOSSEUM 156.472 | 156.472 | 00889095976496 | Height 4 mm; Angle 8 deg; Depth 15 mm; Width 18 mm | On the market |
| COLOSSEUM 156.476 | 156.476 | 00889095976519 | Angle 8 deg; Width 18 mm; Depth 15 mm; Length 8 mm | On the market |
| COLOSSEUM 156.507 | 156.507 | 00889095976571 | Width 16 mm; Height 28 mm; Depth 14 mm | On the market |
| COLOSSEUM 156.511 | 156.511 | 00889095976618 | Depth 14 mm; Width 16 mm; Height 44 mm | On the market |
| COLOSSEUM 156.520 | 156.520 | 00889095976649 | Depth 14 mm; Height 80 mm; Width 16 mm | On the market |
| COLOSSEUM 156.528 | 156.528 | 00889095976670 | Depth 14 mm; Width 16 mm; Height 32 mm | On the market |
| COLOSSEUM 156.531 | 156.531 | 00889095976700 | Depth 14 mm; Height 44 mm; Width 16 mm | On the market |
| COLOSSEUM 156.536 | 156.536 | 00889095976731 | Depth 14 mm; Width 16 mm; Height 64 mm | On the market |
| COLOSSEUM 156.554 | 156.554 | 00889095976809 | Depth 14 mm; Width 16 mm; Height 4 mm | On the market |
| COLOSSEUM 156.564 | 156.564 | 00889095976847 | Height 4 mm; Width 16 mm; Angle 3.5 deg; Depth 14 mm | On the market |
| COLOSSEUM 156.702 | 156.702 | 00889095976892 | Width 23 mm; Depth 21 mm; Height 8 mm | On the market |
| COLOSSEUM 156.715 | 156.715 | 00889095977004 | Depth 21 mm; Width 23 mm; Height 60 mm | On the market |
| COLOSSEUM 156.752 | 156.752 | 00889095977042 | Depth 21 mm; Height 2 mm; Width 23 mm | On the market |
| COLOSSEUM 156.909 | 156.909 | 00889095977226 | Depth 25 mm; Width 30 mm; Height 36 mm | On the market |
| COLOSSEUM 156.910 | 156.910 | 00889095977233 | Height 40 mm; Depth 25 mm; Width 30 mm | On the market |
| COLOSSEUM 156.911 | 156.911 | 00889095977240 | Depth 25 mm; Height 44 mm; Width 30 mm | On the market |
| COLOSSEUM 156.915 | 156.915 | 00889095977264 | Depth 25 mm; Height 60 mm; Width 30 mm | On the market |
| COLOSSEUM 156.930 | 156.930 | 00889095977288 | Height 120 mm; Width 30 mm; Depth 25 mm | On the market |
| COLOSSEUM 156.952 | 156.952 | 00889095977301 | Depth 25 mm; Width 30 mm; Height 2 mm | On the market |
| COLOSSEUM 156.966 | 156.966 | 00889095977356 | Depth 25 mm; Height 8 mm; Width 30 mm; Angle 4 deg | On the market |
| COLOSSEUM 156.972 | 156.972 | 00889095977363 | Height 6 mm; Width 30 mm; Depth 25 mm; Angle 8 deg | On the market |
| COLOSSEUM 156.982 | 156.982 | 00889095977394 | Depth 25 mm; Width 30 mm; Angle 12 deg; Height 8 mm | On the market |
| COLOSSEUM 656.102 | 656.102 | 00889095977455 | On the market | |
| COLOSSEUM 656.104 | 656.104 | 00889095977462 | On the market | |
| COLOSSEUM 656.105 | 656.105 | 00889095977479 | On the market |
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