Construx – Mini Peek VBR
Construx Mini Peek Spacer System - Instrument KIT (47-0012)
7manufacturers in China registered for this device type
50catalogue numbers in this listing
2recalls 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 | Orthofix US LLC, United States |
|---|---|
| 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172437 |
| Record published | 2019-03-19 |
| Record revised | 2026-02-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47-4005 | In distribution | |
| 47-4106 | In distribution | |
| 47-4111 | In distribution | |
| 47-3014 | In distribution | |
| 47-3013C | In distribution | |
| 47-4013C | In distribution | |
| 47-4006 | In distribution | |
| 450434-0001 | In distribution | |
| 47-3014C | In distribution | |
| 47-4013 | In distribution | |
| 47-4110 | In distribution | |
| 47-4012 | In distribution | |
| 47-4008 | In distribution | |
| 47-3106 | In distribution | |
| 47-4011 | In distribution | |
| 47-3113C | In distribution | |
| 47-4108 | In distribution | |
| 47-4114C | In distribution | |
| 47-4014C | In distribution | |
| 47-3006 | In distribution | |
| 47-3008 | In distribution | |
| 47-3114 | In distribution | |
| 47-4113C | In distribution | |
| 47-3112 | In distribution | |
| 47-3009 | In distribution | |
| 47-3011 | In distribution | |
| 47-4007 | In distribution | |
| 47-3012 | In distribution | |
| 47-3113 | In distribution | |
| 47-3111 | In distribution | |
| 47-3007 | In distribution | |
| 47-4014 | In distribution | |
| 47-4114 | In distribution | |
| 47-4107 | In distribution | |
| 47-3108 | In distribution | |
| 47-4113 | In distribution | |
| 47-4112 | In distribution | |
| 47-4010 | In distribution | |
| 450216-0002 | In distribution | |
| 47-3110 | In distribution | |
| 47-4109 | In distribution | |
| 47-3005 | In distribution | |
| 47-4105 | In distribution | |
| 47-3010 | In distribution | |
| 47-4009 | In distribution | |
| 47-3109 | In distribution | |
| 47-3107 | In distribution | |
| 47-3013 | In distribution | |
| 47-3114C | In distribution | |
| 47-3105 | In distribution |
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
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 |
|---|---|---|---|---|---|---|
| Orthofix US LLC | 510(k) number | 2025-11-03 | Class III | Device Design | Labeling contains claims that are not consistently present. | 61977 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-11-03 | Class III | Device Design | Labeling contains claims that are not consistently present. | 40956 |
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.