Impix Manta
IMPIX-MANTA ON HOLDER MEDIUM 6mm - 3°
7manufacturers in China registered for this device type
52catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Medicrea International, France |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-10-23 |
| Record revised | 2022-12-08 (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 | 2023-04-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B20181783 | Withdrawn | |
| B20121706 | Withdrawn | |
| B20181763 | Withdrawn | |
| B20122206 | Withdrawn | |
| B20121773 | Withdrawn | |
| B20121783 | Withdrawn | |
| B20122273 | Withdrawn | |
| B20121770 | Withdrawn | |
| B20121953 | Withdrawn | |
| B20121793 | Withdrawn | |
| B20122276 | Withdrawn | |
| B20121790 | Withdrawn | |
| B20121776 | Withdrawn | |
| B20122296 | Withdrawn | |
| B20121700 | Withdrawn | |
| B20121983 | Withdrawn | |
| B20121766 | Withdrawn | |
| B20181773 | Withdrawn | |
| B20182273 | Withdrawn | |
| B20182283 | Withdrawn | |
| B20181753 | Withdrawn | |
| B20121756 | Withdrawn | |
| B20122260 | Withdrawn | |
| B20122270 | Withdrawn | |
| B20122293 | Withdrawn | |
| B20122203 | Withdrawn | |
| B20121763 | Withdrawn | |
| B20182253 | Withdrawn | |
| B20182263 | Withdrawn | |
| B20181963 | Withdrawn | |
| B20181953 | Withdrawn | |
| B20121780 | Withdrawn | |
| B20181973 | Withdrawn | |
| B20122283 | Withdrawn | |
| B20121750 | Withdrawn | |
| B20122290 | Withdrawn | |
| B20122266 | Withdrawn | |
| B20121796 | Withdrawn | |
| B20181983 | Withdrawn | |
| B20122250 | Withdrawn | |
| B20121703 | Withdrawn | |
| B20121753 | Withdrawn | |
| B20122200 | Withdrawn | |
| B20122256 | Withdrawn | |
| B20122286 | Withdrawn | |
| B20121786 | Withdrawn | |
| B20122280 | Withdrawn | |
| B20122253 | Withdrawn | |
| B20121963 | Withdrawn | |
| B20121973 | Withdrawn | |
| B20122263 | Withdrawn | |
| B20121760 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100484 | 2010-03-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medicrea International | UDI-DI | 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. | 4489 units |
Recalls
2 of these are 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. | |
| 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. | 0 (US) |
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.