Zavation
Varisync® F3D-Z Modular Alif CAGE26MM X 35MM X 12MM 15°
3manufacturers in China registered for this device type
1,157catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Zavation, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K230731 |
| Record published | 2024-01-09 |
| Record revised | 2024-11-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 869-1008-2540-21-S | In distribution | |
| 861-WH-0840-11 | In distribution | |
| 861-0830-11 | In distribution | |
| 470-1000-6 | In distribution | |
| 863-5515V | In distribution | |
| 210-5555 | In distribution | |
| 212-7585 | In distribution | |
| 861-WH-3030-15 | In distribution | |
| 869-1003-25 | In distribution | |
| 869-1008-0840-14-S | In distribution | |
| 861-2530-17 | In distribution | |
| 861-WH-3040-25 | In distribution | |
| 869-1008-3040-21-S | In distribution | |
| 861-F3D-2035-15 | In distribution | |
| 213-5525 | In distribution | |
| 861-WH-0835-21 | In distribution | |
| 470-081855-06 | In distribution | |
| 861-2535-15 | In distribution | |
| 470-101860-00 | In distribution | |
| 210-8525 | In distribution | |
| 861-LB-2530-15 | In distribution | |
| 861-2530-19 | In distribution | |
| 869-1008-0835-14-S | In distribution | |
| 212-7540 | In distribution | |
| 869-1008-1535-17-R | In distribution | |
| 869-1011 | In distribution | |
| 863-5015F | In distribution | |
| 861-LB-0835-19 | In distribution | |
| 861-3Z-0835-19 | In distribution | |
| 866-20-13 | In distribution | |
| 861-LB-0830-13 | In distribution | |
| 212-8590 | In distribution | |
| 860-30-17 | In distribution | |
| 860-25-15 | In distribution | |
| 869-1008-0835-11-S | In distribution | |
| 864-5515F | In distribution | |
| 184-4030 | In distribution | |
| 210-6595 | In distribution | |
| 861-1530-13 | In distribution | |
| 861-0830-19 | In distribution | |
| 869-1008-0830-17-R | In distribution | |
| 210-1005-50 | In distribution | |
| 869-1008-3035-23-R | In distribution | |
| 212-8595 | In distribution | |
| 470-121855-00 | In distribution | |
| 212-6540 | In distribution | |
| 861-LB-2040-19 | In distribution | |
| 869-1008-3035-19-S | In distribution | |
| 0100053 | In distribution | |
| 180S-0833-15 | In distribution | |
| 861-WH-3030-25 | In distribution | |
| 869-1008-1540-13-S | In distribution | |
| 210-1005-45 | In distribution | |
| 869-1008-2535-21-S | In distribution | |
| 210-7575 | In distribution | |
| 861-F3D-0840-19 | In distribution | |
| 861-0830-15 | In distribution | |
| 212-6535 | In distribution | |
| 861-2030-19 | In distribution | |
| 210-7590 | In distribution | |
| 210-7530 | In distribution | |
| 861-2540-17 | In distribution | |
| 869-1008-3030-15-R | In distribution | |
| 180-1538-19 | In distribution | |
| 470-162240-06 | In distribution | |
| 861-LB-2530-21 | In distribution | |
| 861-LB-1540-21 | In distribution | |
| 180S-1538-13 | In distribution | |
| 861-2035-21 | In distribution | |
| 860-25-21 | In distribution | |
| 180S-1538-19 | In distribution | |
| 861-WH-3030-19 | In distribution | |
| 470-082660-00 | In distribution | |
| 869-1008-3030-25-S | In distribution | |
| 866-15-12 | In distribution | |
| 470-101845-12 | In distribution | |
| 861-0835-13 | In distribution | |
| 861-1530-15 | In distribution | |
| 210-1001-25 | In distribution | |
| 470-122255-12 | In distribution | |
| 866-25-15 | In distribution | |
| 861-0840-12 | In distribution | |
| 861-F3D-0830-13 | In distribution | |
| 861-LB-2035-13 | In distribution | |
| 861-LB-0840-21 | In distribution | |
| 869-1017 | In distribution | |
| 860-30-23 | In distribution | |
| 869-1026-20 | In distribution | |
| 869-1008-3030-25-R | In distribution | |
| 867-20-13 | In distribution | |
| 869-1008-2530-15-R | In distribution | |
| 861-3Z-0835-13 | In distribution | |
| 180S-0838-17 | In distribution | |
| 470-122645-00 | In distribution | |
| 861-2035-13 | In distribution | |
| 210-8565 | In distribution | |
| 864-5515V | In distribution | |
| 861-LB-1540-19 | In distribution | |
| 863-6020F | In distribution | |
| 869-1003-23 | In distribution | |
| 470-122250-00 | In distribution | |
| 212-7565 | In distribution | |
| 861-3030-21 | In distribution | |
| 869-1008-0835-17-S | In distribution | |
| 861-3030-15 | In distribution | |
| 861-LB-0835-13 | In distribution | |
| 861-0830-17 | In distribution | |
| 0100025 | In distribution | |
| 861-WH-1535-19 | In distribution | |
| 470-102640-06 | In distribution | |
| 861-F3D-1530-12 | In distribution | |
| 0100134 | In distribution | |
| ZAV-1146-1 | In distribution | |
| 861-F3D-2035-13 | In distribution | |
| 210-6540 | In distribution | |
| 470-082250-06 | In distribution | |
| 180-0833-17 | In distribution | |
| 869-1008-0835-17-R | In distribution | |
| 861-F3D-0835-11 | In distribution | |
| 861-F3D-0830-15 | In distribution | |
| 869-1008-1540-13-R | In distribution | |
| 861-LB-1535-15 | In distribution | |
| 861-2530-21 | In distribution | |
| 0100036 | In distribution | |
| 863-5035F | In distribution | |
| 869-1003-19 | In distribution | |
| 470-161850-12 | In distribution | |
| 863-5535F | In distribution | |
| ZAV-1147 | In distribution | |
| 869-1008-0835-21-R | In distribution | |
| 861-WH-0830-15 | In distribution | |
| 869-1008-2535-19-R | In distribution | |
| 869-1008-1530-17-S | In distribution | |
| 869-1014 | In distribution | |
| 869-1008-0830-14-S | In distribution | |
| 180-1538-13 | In distribution | |
| 866-08-14 | In distribution | |
| 863-5040V | In distribution | |
| 863-5525F | In distribution | |
| 861-0835-21 | In distribution | |
| 210-1001-35 | In distribution | |
| 861-F3D-1530-14 | In distribution | |
| 860-25-19 | In distribution | |
| 861-LB-0835-12 | In distribution | |
| 0100083 | In distribution | |
| 869-1008-1535-19-R | In distribution | |
| 861-0835-19 | In distribution | |
| 180-0838-13 | In distribution | |
| 210-1001-55 | In distribution | |
| 861-F3D-2530-15 | In distribution | |
| 470-162645-06 | In distribution | |
| 869-1008-0840-21-R | In distribution | |
| 212-6525 | In distribution | |
| 470-2001-40 | In distribution | |
| 869-1008-2035-19-S | In distribution | |
| 210-5560 | In distribution | |
| 210-7565 | In distribution | |
| 470-161845-06 | In distribution | |
| 861-LB-3035-23 | In distribution | |
| 860-15-17 | In distribution | |
| 860-20-14 | In distribution | |
| 869-1008-2040-21-S | In distribution | |
| 869-1008-1530-11-R | In distribution | |
| 861-LB-0840-12 | In distribution | |
| 860-15-19 | In distribution | |
| 861-3Z-0830-12 | In distribution | |
| 861-WH-2530-19 | In distribution | |
| 861-LB-2535-17 | In distribution | |
| 212-8525 | In distribution | |
| 861-WH-2535-15 | In distribution | |
| 861-LB-2535-21 | In distribution | |
| 869-1008-1540-14-R | In distribution | |
| 861-3Z-0830-14 | In distribution | |
| 0100079 | In distribution | |
| 470-161855-12 | In distribution | |
| 861-F3D-1535-17 | In distribution | |
| 180S-0833-19 | In distribution | |
| 860-30-21 | In distribution | |
| 869-1032-25 | In distribution | |
| 861-LB-1535-12 | In distribution | |
| 861-F3D-2040-15 | In distribution | |
| 210-5540 | In distribution | |
| 210-6545 | In distribution | |
| 869-1008-0835-14-R | In distribution | |
| 861-WH-2535-19 | In distribution | |
| 861-LB-2540-19 | In distribution | |
| 869-1008-0840-15-R | In distribution | |
| 861-WH-2030-14 | In distribution | |
| 210-6530 | In distribution | |
| 860-08-12 | In distribution | |
| 170-2009 | In distribution | |
| 0100003 | In distribution | |
| 863-5520F | In distribution | |
| 470-081845-00 | In distribution | |
| 861-3040-23 | In distribution | |
| 863-5530V | In distribution | |
| 212-5560 | In distribution | |
| 869-1008-1535-15-S | In distribution | |
| 861-F3D-1540-17 | In distribution | |
| 866-15-19 | In distribution | |
| 470-122655-00 | In distribution | |
| 0100020 | In distribution | |
| 210-7570 | In distribution | |
| 861-0840-17 | In distribution | |
| 861-F3D-1540-19 | In distribution | |
| 0100056 | In distribution | |
| 861-LB-0840-15 | In distribution | |
| 210-5565 | In distribution | |
| 866-08-12 | In distribution | |
| 861-3Z-0830-19 | In distribution | |
| 861-F3D-3030-23 | In distribution | |
| 861-0830-14 | In distribution | |
| 867-20-14 | In distribution | |
| 0100105 | In distribution | |
| 470-162255-12 | In distribution | |
| 180-0833-11 | In distribution | |
| 212-5525 | In distribution | |
| 213-7550 | In distribution | |
| 861-0840-14 | In distribution | |
| 867-25-21 | In distribution | |
| 0100111 | In distribution | |
| 210-1005-55 | In distribution | |
| 861-WH-2030-19 | In distribution | |
| 860-20-17 | In distribution | |
| 470-081855-12 | In distribution | |
| 0100030 | In distribution | |
| 861-3Z-0830-11 | In distribution | |
| 170-2006 | In distribution | |
| 470-161860-00 | In distribution | |
| 470-142650-06 | In distribution | |
| 869-1008-0840-19-R | In distribution | |
| 183-4015 | In distribution | |
| 867-08-11 | In distribution | |
| 861-2535-17 | In distribution | |
| 861-1530-11 | In distribution | |
| 869-1008-1535-13-S | In distribution | |
| 869-1008-2040-17-R | In distribution | |
| 212-8575 | In distribution | |
| 864-6030F | In distribution | |
| 212-7590 | In distribution | |
| 869-1032-15 | In distribution | |
| 861-F3D-1530-15 | In distribution | |
| 861-LB-3030-21 | In distribution | |
| 869-1032-17 | In distribution | |
| 869-1008-2035-17-S | In distribution | |
| 180S-1538-17 | In distribution | |
| 861-3035-21 | In distribution | |
| 867-08-17 | In distribution | |
| 861-F3D-1535-19 | In distribution | |
| 470-141850-00 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 453 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142271 | 2014-12-19 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.