FORTIFY Corpectomy Spacers
FDA 510(k) clearance K173982 · decided 2018-09-19
Clearance details
- K-number
- K173982
- Device name
- FORTIFY Corpectomy Spacers
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-29
- Decision date
- 2018-09-19
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- MQP
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vertiwedge® Intraosseous System (K261810) | Foundation Surgical Group | 2026-07-31 |
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| KONG®-TL VBR System and KONG® C VBR System (K232790) | Icotec AG | 2024-04-04 |
| DOMINION Expandable Corpectomy System (K233359) | Astura Medical | 2024-03-08 |
| VerteLoc Spinal System (K231134) | Signature Orthopaedics Pty, Ltd. | 2024-02-13 |
| Ascend VBR System, Ascend NanoTec VBR System (K232173) | Alphatec Spine, Inc. | 2023-10-06 |
| ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (K211892) | Arftx Medical, LLC | 2022-10-06 |
| F3D Corpectomy System (K202637) | Corelink, LLC | 2020-12-23 |
| KONG-TL VBR System, KONG-C VBR System (K200235) | Icotec AG | 2020-05-29 |
| NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System (K193506) | Nu Vasive, Incorporated | 2020-02-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |