Impix Alif S/A
IMPACTION SOCKET -MEDIUM- 10 to 14 mm WITHOUT END STOP
3manufacturers in China registered for this device type
172catalogue numbers in this listing
1510(k) clearance
1recall
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 | Medicrea International, France |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-10-23 |
| Record revised | 2023-01-11 (version 8) |
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 | 2025-12-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B15201412 | Withdrawn | |
| B15201200 | Withdrawn | |
| B15274532 | Withdrawn | |
| B15221003 | Withdrawn | |
| B15222009 | Withdrawn | |
| B15201809 | Withdrawn | |
| A15240012 | Withdrawn | |
| B15221206 | Withdrawn | |
| B15241012 | Withdrawn | |
| B15221403 | Withdrawn | |
| B15202006 | Withdrawn | |
| B15275530 | Withdrawn | |
| B15211403 | Withdrawn | |
| B15201206 | Withdrawn | |
| A15220021 | Withdrawn | |
| B15234532 | Withdrawn | |
| B15211412 | Withdrawn | |
| B15234526 | Withdrawn | |
| A15220012 | Withdrawn | |
| B15212006 | Withdrawn | |
| B15221415 | Withdrawn | |
| B15202012 | Withdrawn | |
| B15241015 | Withdrawn | |
| B15212009 | Withdrawn | |
| A15200021 | Withdrawn | |
| B15201409 | Withdrawn | |
| B15235524 | Withdrawn | |
| B15231209 | Withdrawn | |
| A15220032 | Withdrawn | |
| B15221609 | Withdrawn | |
| B15231409 | Withdrawn | |
| B15201803 | Withdrawn | |
| B15211612 | Withdrawn | |
| A15240011 | Withdrawn | |
| B15205501 | Withdrawn | |
| B15221600 | Withdrawn | |
| B15211609 | Withdrawn | |
| B15274528 | Withdrawn | |
| B15201212 | Withdrawn | |
| B15235526 | Withdrawn | |
| B15235522 | Withdrawn | |
| B15235528 | Withdrawn | |
| B15211015 | Withdrawn | |
| B15221603 | Withdrawn | |
| B15222012 | Withdrawn | |
| A15210013 | Withdrawn | |
| A15200012 | Withdrawn | |
| B15231212 | Withdrawn | |
| B15211009 | Withdrawn | |
| B15211812 | Withdrawn | |
| B15221612 | Withdrawn | |
| A15200032 | Withdrawn | |
| A15200013 | Withdrawn | |
| B15211806 | Withdrawn | |
| B15221012 | Withdrawn | |
| B15201006 | Withdrawn | |
| B15235530 | Withdrawn | |
| B15221809 | Withdrawn | |
| B15211000 | Withdrawn | |
| B15201406 | Withdrawn | |
| B15211809 | Withdrawn | |
| B15201612 | Withdrawn | |
| B15275532 | Withdrawn | |
| B15201609 | Withdrawn | |
| B15202009 | Withdrawn | |
| B15211409 | Withdrawn | |
| B15221015 | Withdrawn | |
| B15204501 | Withdrawn | |
| B15211615 | Withdrawn | |
| B15221409 | Withdrawn | |
| B15211206 | Withdrawn | |
| A15210012 | Withdrawn | |
| B15201012 | Withdrawn | |
| B15201215 | Withdrawn | |
| B15275526 | Withdrawn | |
| B15211800 | Withdrawn | |
| B15201003 | Withdrawn | |
| B15234530 | Withdrawn | |
| B15201400 | Withdrawn | |
| B15221212 | Withdrawn | |
| B15221203 | Withdrawn | |
| B15201606 | Withdrawn | |
| B15211400 | Withdrawn | |
| B15202015 | Withdrawn | |
| B15221812 | Withdrawn | |
| B15201009 | Withdrawn | |
| B15211200 | Withdrawn | |
| B15211003 | Withdrawn | |
| A15210011 | Withdrawn | |
| B15211012 | Withdrawn | |
| B15221800 | Withdrawn | |
| B15221200 | Withdrawn | |
| B15274530 | Withdrawn | |
| B15221606 | Withdrawn | |
| A15220022 | Withdrawn | |
| B15234524 | Withdrawn | |
| B15221406 | Withdrawn | |
| B15201403 | Withdrawn | |
| B15211212 | Withdrawn | |
| B15221006 | Withdrawn | |
| A15200031 | Withdrawn | |
| B15221000 | Withdrawn | |
| B15241409 | Withdrawn | |
| B15235532 | Withdrawn | |
| B15231015 | Withdrawn | |
| B15221400 | Withdrawn | |
| B15201600 | Withdrawn | |
| B15211406 | Withdrawn | |
| A15220013 | Withdrawn | |
| A15200022 | Withdrawn | |
| A15250011 | Withdrawn | |
| B15211203 | Withdrawn | |
| B15201415 | Withdrawn | |
| B15221009 | Withdrawn | |
| B15201209 | Withdrawn | |
| B15201815 | Withdrawn | |
| B15214501 | Withdrawn | |
| B15241209 | Withdrawn | |
| B15234522 | Withdrawn | |
| B15201812 | Withdrawn | |
| B15222015 | Withdrawn | |
| B15241212 | Withdrawn | |
| B15211415 | Withdrawn | |
| B15274526 | Withdrawn | |
| B15221209 | Withdrawn | |
| B15201203 | Withdrawn | |
| B15201615 | Withdrawn | |
| B15202000 | Withdrawn | |
| B15224501 | Withdrawn | |
| B15241412 | Withdrawn | |
| B15211815 | Withdrawn | |
| B15215501 | Withdrawn | |
| B15222000 | Withdrawn | |
| B15201806 | Withdrawn | |
| B15222003 | Withdrawn | |
| B15225501 | Withdrawn | |
| B15201000 | Withdrawn | |
| B15212015 | Withdrawn | |
| B15221412 | Withdrawn | |
| B15211803 | Withdrawn | |
| B15211603 | Withdrawn | |
| B15211600 | Withdrawn | |
| A15210022 | Withdrawn | |
| B15212003 | Withdrawn | |
| B15201603 | Withdrawn | |
| B15201800 | Withdrawn | |
| B15221803 | Withdrawn | |
| B15275528 | Withdrawn | |
| B15211215 | Withdrawn | |
| B15222006 | Withdrawn | |
| B15221615 | Withdrawn | |
| B15212000 | Withdrawn | |
| B15221806 | Withdrawn | |
| B15201015 | Withdrawn | |
| A15220031 | Withdrawn | |
| B15211006 | Withdrawn | |
| A15210031 | Withdrawn | |
| A15250012 | Withdrawn | |
| B15241009 | Withdrawn | |
| B15231012 | Withdrawn | |
| A15210032 | Withdrawn | |
| B15231009 | Withdrawn | |
| A15200011 | Withdrawn | |
| B15211209 | Withdrawn | |
| B15211606 | Withdrawn | |
| B15221215 | Withdrawn | |
| A15220011 | Withdrawn | |
| A15210021 | Withdrawn | |
| B15221815 | Withdrawn | |
| B15202003 | Withdrawn | |
| B15231412 | Withdrawn | |
| B15212012 | Withdrawn |
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 |
| Zavation | Zavation | 1,157 |
| 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 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141187 | 2015-01-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-07-12 | Class II | Under Investigation by firm | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. | 5 units |
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.