F3D Corpectomy System
by Corelink LLC
510(k) K202637
F3D Corpectomy System is a Class II device made by Corelink LLC, cleared under FDA 510(k) K202637 on 23 Dec 2020, 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 | NumberK202637 | Date23 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K202637
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQP
- FDA applicant
- Corelink, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K202637
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 | |||
|---|---|---|---|---|
| ZAVATION F3D CORPECTOMY 3CM1412-0058 | 3CM1412-0058 | 00197157060152 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1412-0715 | 3CM1412-0715 | 00197157060336 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1412-0773 | 3CM1412-0773 | 00197157060916 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1412-1225 | 3CM1412-1225 | 00197157061043 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1412-1252 | 3CM1412-1252 | 00197157061319 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-0045 | 3CM1613-0045 | 00197157061852 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-0049 | 3CM1613-0049 | 00197157061890 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-0724 | 3CM1613-0724 | 00197157062255 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-0728 | 3CM1613-0728 | 00197157062293 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-0742 | 3CM1613-0742 | 00197157062439 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-1219 | 3CM1613-1219 | 00197157062811 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-1230 | 3CM1613-1230 | 00197157062927 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-1249 | 3CM1613-1249 | 00197157063115 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-1251 | 3CM1613-1251 | 00197157063139 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1613-1257 | 3CM1613-1257 | 00197157063191 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1814-0047 | 3CM1814-0047 | 00197157063702 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1816-0023 | 3CM1816-0023 | 00197157065294 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1816-0029 | 3CM1816-0029 | 00197157065355 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1816-0044 | 3CM1816-0044 | 00197157065508 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1816-0742 | 3CM1816-0742 | 00197157066093 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1816-0748 | 3CM1816-0748 | 00197157066154 | On the market | |
| ZAVATION F3D CORPECTOMY 3CM1816-1267 | 3CM1816-1267 | 00197157066956 | On the market | |
| ZAVATION VBR TRIAL 02C01957 | 02C01957 | 00197157050986 | On the market | |
| ZAVATION VBR TRIAL 02C01967 | 02C01967 | 00197157051082 | On the market | |
| ZAVATION VBR TRIAL 02C01986 | 02C01986 | 00197157051273 | On the market | |
| ZAVATION VBR TRIAL 02C01995 | 02C01995 | 00197157051365 | On the market | |
| ZAVATION VBR TRIAL 02C01997 | 02C01997 | 00197157051389 | On the market | |
| ZAVATION VBR TRIAL 02C02029 | 02C02029 | 00197157051709 | On the market | |
| ZAVATION VBR TRIAL 02C02037 | 02C02037 | 00197157051785 | On the market | |
| ZAVATION VBR TRIAL 02C02049 | 02C02049 | 00197157051907 | On the market | |
| ZAVATION VBR TRIAL 02C02055 | 02C02055 | 00197157051969 | On the market | |
| ZAVATION VBR TRIAL 02C02074 | 02C02074 | 00197157052157 | On the market | |
| ZAVATION VBR TRIAL 02C02283 | 02C02283 | 00197157052416 | On the market | |
| ZAVATION VBR TRIAL 02C02300 | 02C02300 | 00197157052584 | On the market | |
| ZAVATION VBR TRIAL 02C02322 | 02C02322 | 00197157052805 | On the market | |
| ZAVATION VBR TRIAL 02C02331 | 02C02331 | 00197157052898 | On the market | |
| ZAVATION VBR TRIAL 02C02349 | 02C02349 | 00197157053079 | On the market | |
| ZAVATION VBR TRIAL 02C02368 | 02C02368 | 00197157053260 | On the market | |
| ZAVATION VBR TRIAL 02C02384 | 02C02384 | 00197157053420 | On the market | |
| ZAVATION VBR TRIAL 02C02402 | 02C02402 | 00197157053604 | On the market | |
| ZAVATION VBR TRIAL 02C02446 | 02C02446 | 00197157054045 | On the market | |
| ZAVATION VBR TRIAL 02C02678 | 02C02678 | 00197157054533 | On the market | |
| ZAVATION VBR TRIAL 02C02691 | 02C02691 | 00197157054663 | On the market | |
| ZAVATION VBR TRIAL 02C02695 | 02C02695 | 00197157054700 | On the market | |
| ZAVATION VBR TRIAL 02C02701 | 02C02701 | 00197157054762 | On the market | |
| ZAVATION VBR TRIAL 02C02709 | 02C02709 | 00197157054847 | On the market | |
| ZAVATION VBR TRIAL 02C02714 | 02C02714 | 00197157054892 | On the market | |
| ZAVATION VBR TRIAL 02C02723 | 02C02723 | 00197157054984 | On the market | |
| ZAVATION VBR TRIAL 02C02724 | 02C02724 | 00197157054991 | On the market | |
| ZAVATION VBR TRIAL 02C02800 | 02C02800 | 00197157055752 | On the market |
Similar devices
Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).
- XPAND CORPECTOMY SPACER by GLOBUS MEDICAL, INC.
- CONCORDE 196927010 by MEDOS INTERNATIONAL SARL
- BENGAL STACKABLE CAGE SYSTEM by Depuy Spine, Inc.
- BLACKSTONE SURGICAL TITANIUM MESH by Blackstone Medical, Inc.
- PYRAMESH® C Titanium Mesh 905-403 by MEDTRONIC SOFAMOR DANEK, INC.
- Vertiwedge® Intraosseous System by FOUNDATION SURGICAL GROUP
- XYCOR SPINAL IMPLANT by Vertebration, Inc
- MODIFICATION TO GEO STRUCTURE by Interpore Cross Intl.
- STAXX XD SYSTEM by Spine Wave, Inc.
- FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 by Spine Next America Corporation