Zevo™ Anterior Cervical Plate System
Plate G3005077 Zevo 77MM 5 LVL
2manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HBA |
| Device type | Neurosurgical Paddie |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4700 |
| 510(k) | K141632 |
| Record published | 2015-10-16 |
| Record revised | 2025-11-20 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3005079 | In distribution | |
| 3005077 | In distribution | |
| G3005077 | In distribution | |
| 3005095 | In distribution | |
| 3005100 | In distribution | |
| 3005100 | In distribution | |
| 3005075 | In distribution | |
| G3005090 | In distribution | |
| G3005095 | In distribution | |
| 3005079 | In distribution | |
| 3005095 | In distribution | |
| 3005105 | In distribution | |
| 3005090 | In distribution | |
| 3005108 | In distribution | |
| G3005077 | In distribution | |
| G3005095 | In distribution | |
| G3005090 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OMT LLC | OMT, LLC | 126 |
| Neuray ® | Medtronic Xomed, Inc. | 63 |
| Codman® | Integra LifeSciences Production Corporation | 42 |
| Codman | Cerenovus, Inc. | 41 |
| Americot | American Surgical Company, LLC | 39 |
| Spetzler Neuro Patties | OMT, LLC | 35 |
| Merocel | Medtronic Xomed, Inc. | 34 |
| Ray-Cot | American Surgical Company, LLC | 26 |
| Uniqcot | American Surgical Company, LLC | 24 |
| Medline | Medline Industries, Inc. | 19 |
| Ultracot | American Surgical Company, LLC | 15 |
| Telfa | American Surgical Company, LLC | 13 |
Showing 12 of 24. All products under Neurosurgical Paddie
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2018-03-23 | Class II | Process control | Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. | 39 units | 2021-07-25 |
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.