Construx – Peek VBR
23MM Lateral Spacer, 4DEG Lordotic - 26MM (26MM ANT./24MM Post.)
3manufacturers in China registered for this device type
142catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K060350 |
| 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 |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Height 5 to 12 mm; width 12 mm; length 12 to 15 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45-3251 | In distribution | |
| 45-2103 | In distribution | |
| 45-3104 | In distribution | |
| 45-1072 | In distribution | |
| 45-2221 | In distribution | |
| 45-2326 | In distribution | |
| 45-6311 | In distribution | |
| 45-3226 | In distribution | |
| 45-2211 | In distribution | |
| 45-2208 | In distribution | |
| 45-2308 | In distribution | |
| 47-4112C | Height 12 mm | In distribution |
| 47-3006C | Height 6 mm | In distribution |
| 47-3008C | Height 8 mm | In distribution |
| 45-6316 | In distribution | |
| 45-3221 | In distribution | |
| 45-3313 | In distribution | |
| 47-3009C | Height 9 mm | In distribution |
| 45-2116 | In distribution | |
| 45-2114 | In distribution | |
| 47-4012C | Height 12 mm | In distribution |
| 47-3110C | Height 10 mm | In distribution |
| 45-6306 | In distribution | |
| 45-2331 | In distribution | |
| 45-3321 | In distribution | |
| 45-3351 | In distribution | |
| 45-3241 | In distribution | |
| 45-6308 | In distribution | |
| 45-1075 | In distribution | |
| 45-2408 | In distribution | |
| 45-6310 | In distribution | |
| 47-3108C | Height 8 mm | In distribution |
| 47-3105C | In distribution | |
| 45-3315 | In distribution | |
| 45-2212 | In distribution | |
| 45-3406 | In distribution | |
| 47-3010C | Height 10 mm | In distribution |
| 45-3314 | In distribution | |
| 47-4108C | Height 8 mm | In distribution |
| 45-2213 | In distribution | |
| 450204-0001 | In distribution | |
| 45-2514 | In distribution | |
| 45-3316 | In distribution | |
| 45-3256 | In distribution | |
| 45-2209 | In distribution | |
| 47-4007C | Height 7 mm | In distribution |
| 47-4005C | Height 5 mm | In distribution |
| 45-2112 | In distribution | |
| 45-2231 | In distribution | |
| 45-3208 | In distribution | |
| 45-2346 | In distribution | |
| 45-2321 | In distribution | |
| 47-3107C | Height 7 mm | In distribution |
| 45-3341 | In distribution | |
| 45-6309 | In distribution | |
| 47-4106C | Height 6 mm | In distribution |
| 45-3310 | In distribution | |
| 47-3011C | Height 11 mm | In distribution |
| 47-3106C | Height 6 mm | In distribution |
| 45-2102 | In distribution | |
| 45-2256 | In distribution | |
| 45-2216 | In distribution | |
| 45-2316 | In distribution | |
| 45-2215 | In distribution | |
| 45-2236 | In distribution | |
| 45-3209 | In distribution | |
| 45-3108 | In distribution | |
| 45-6315 | In distribution | |
| 45-2315 | In distribution | |
| 45-2508 | In distribution | |
| 45-2246 | In distribution | |
| 45-2314 | In distribution | |
| 47-3111C | Height 11 mm | In distribution |
| 47-4008C | Height 8 mm | In distribution |
| 47-3109C | Height 9 mm | In distribution |
| 45-6313 | In distribution | |
| 47-4110C | Height 10 mm | In distribution |
| 47-4109C | Height 9 mm | In distribution |
| 45-3356 | In distribution | |
| 45-3106 | In distribution | |
| 45-6314 | In distribution | |
| 45-3231 | In distribution | |
| 450217-0001 | In distribution | |
| 45-3216 | In distribution | |
| 45-3346 | In distribution | |
| 47-3007C | Height 7 mm | In distribution |
| 45-2106 | In distribution | |
| 45-3103 | In distribution | |
| 45-6307 | In distribution | |
| 45-2512 | In distribution | |
| 450205-0001 | In distribution | |
| 45-2214 | In distribution | |
| 45-2241 | In distribution | |
| 45-3214 | In distribution | |
| 45-3213 | In distribution | |
| 45-3331 | In distribution | |
| 45-3215 | In distribution | |
| 45-2351 | In distribution | |
| 45-1073 | In distribution | |
| 45-3326 | In distribution | |
| 45-3311 | In distribution | |
| 45-6312 | In distribution | |
| 45-3236 | In distribution | |
| 45-2104 | In distribution | |
| 47-4011C | Height 11 mm | In distribution |
| 45-3506 | In distribution | |
| 45-3408 | In distribution | |
| 45-2312 | In distribution | |
| 47-4006C | Height 6 mm | In distribution |
| 45-2108 | In distribution | |
| 45-2516 | In distribution | |
| 45-1074 | In distribution | |
| 47-3112C | Height 12 mm | In distribution |
| 45-2226 | In distribution | |
| 45-3508 | In distribution | |
| 45-1076 | In distribution | |
| 45-1071 | In distribution | |
| 45-2210 | In distribution | |
| 47-4105C | Height 5 mm | In distribution |
| 47-4107C | Height 7 mm | In distribution |
| 45-2251 | In distribution | |
| 45-3246 | In distribution | |
| 45-3102 | In distribution | |
| 45-2310 | In distribution | |
| 45-3212 | In distribution | |
| 45-2356 | In distribution | |
| 45-2506 | In distribution | |
| 47-3005C | Height 5 mm | In distribution |
| 45-3210 | In distribution | |
| 45-2311 | In distribution | |
| 47-4009C | Height 9 mm | In distribution |
| 47-4111C | Height 11 mm | In distribution |
| 47-4010C | Height 10 mm | In distribution |
| 45-2406 | In distribution | |
| 47-3012C | Height 12 mm | In distribution |
| 450203-0001 | In distribution | |
| 45-3312 | In distribution | |
| 45-2341 | In distribution | |
| 45-2313 | In distribution | |
| 45-2336 | In distribution | |
| 45-3211 | In distribution | |
| 45-3336 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-11-19 | Not classified | Nonconforming Material/Component | The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning. | 29 instruments | 2010-02-02 |
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.