FORTIFY Corpectomy Spacers
by Globus Medical, Inc. 2 variants
510(k) K162315
FORTIFY Corpectomy Spacers is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K162315 on 9 Nov 2017, 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 | NumberK162315 | Date9 Nov 2017 | StatusActive |
Official records
- FDA 510(k) database K162315
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- Withdrawn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 K162315
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 | |||
|---|---|---|---|---|
| FORTIFY 151.001S | 151.001S | 00889095615791 | — | On the market |
| FORTIFY 151.002S | 151.002S | 00889095615807 | — | On the market |
| FORTIFY 151.003S | 151.003S | 00889095615814 | — | On the market |
| FORTIFY 151.004S | 151.004S | 00889095615821 | — | On the market |
| FORTIFY 151.050S | 151.050S | 00889095615838 | — | On the market |
| FORTIFY 151.051S | 151.051S | 00889095615845 | — | On the market |
| FORTIFY 151.052S | 151.052S | 00889095615852 | — | On the market |
| FORTIFY 151.053S | 151.053S | 00889095615869 | — | On the market |
| FORTIFY 151.054S | 151.054S | 00889095615876 | — | On the market |
| FORTIFY 151.055S | 151.055S | 00889095615883 | — | On the market |
| FORTIFY 151.320S | 151.320S | 00889095616651 | — | On the market |
| FORTIFY 151.321S | 151.321S | 00889095616668 | — | On the market |
| FORTIFY 151.322S | 151.322S | 00889095616675 | — | On the market |
| FORTIFY 151.323S | 151.323S | 00889095616682 | — | On the market |
| FORTIFY 151.324S | 151.324S | 00889095616699 | — | On the market |
| FORTIFY 151.331S | 151.331S | 00889095616729 | — | On the market |
| FORTIFY 151.333S | 151.333S | 00889095616743 | — | On the market |
| FORTIFY 151.334S | 151.334S | 00889095616750 | — | On the market |
| FORTIFY 151.371S | 151.371S | 00889095616965 | — | On the market |
| FORTIFY 151.373S | 151.373S | 00889095616989 | — | On the market |
| FORTIFY 151.374S | 151.374S | 00889095616996 | — | On the market |
| FORTIFY 151.381S | 151.381S | 00889095617023 | — | On the market |
| FORTIFY 151.383S | 151.383S | 00889095617047 | — | On the market |
| FORTIFY 151.384S | 151.384S | 00889095617054 | — | On the market |
| FORTIFY 151.385S | 151.385S | 00889095617061 | — | On the market |
| FORTIFY 151.701S | 151.701S | 00889095618969 | — | On the market |
| FORTIFY 151.703S | 151.703S | 00889095618983 | — | On the market |
| FORTIFY 151.704S | 151.704S | 00889095618990 | — | On the market |
| FORTIFY 151.751S | 151.751S | 00889095619027 | — | On the market |
| FORTIFY 151.753S | 151.753S | 00889095619041 | — | On the market |
| FORTIFY 151.754S | 151.754S | 00889095619058 | — | On the market |
| FORTIFY 151.755S | 151.755S | 00889095619065 | — | On the market |
Similar devices
Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).
- VISTA -S DEVICE by Zimmer Trabecular Metal Technology, Inc.
- BENGAL 177300320 by Depuy Spine, Inc.
- SYNMESH System by Depuy Synthes Spine
- BENGAL 177304409 by Depuy Spine, Inc.
- CONCORDE 187823411 by MEDOS INTERNATIONAL SARL
- KONG-C VBR System, Trial End Plate, 6° / 14 x 13 mm 43-146 by icotec AG
- HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ by Implex Corp.
- GEO STRUCTURE by Interpore Cross Intl.
- ATLAS SPINE SPACER by ATLAS SPINE INC.
- SYNFIX -LR by Synthes Spine Co.Lp