Breckenridge Intervertebral Body/VBR Fusion System
228 catalogue numbers from 8880-6118, listed by Biomet Spine, United States, under Spinal Vertebral Body Replacement Device. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
228catalogue numbers in this listing
1510(k) clearance
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 | Biomet Spine, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2015-10-24 |
| Record revised | 2025-01-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8880-6118 | ALIF PEEK 15° 24X32X18MM | In distribution |
| 8824-4310 | ACDF PEEK 0° 14x18x10mm | In distribution |
| 8825-0713 | VBR PEEK 7°/0° 14X18X13MM | In distribution |
| 8814-1208 | ACF PEEK 5° 12X14X8MM | In distribution |
| 8880-5210 | ALIF PEEK 12° 27x36x10mm | In distribution |
| 8880-6114 | ALIF PEEK 15° 24X32X14MM | In distribution |
| 8825-0727 | VBR PEEK 7°/0° 14X18X27MM | In distribution |
| 8880-0216 | ALIF PEEK 0° 27x36x16mm | In distribution |
| 8824-3110 | ACDF PEEK Convex 14x12x10mm | In distribution |
| 8804-1245 | VBR PEEK 0° 12X14X45MM | In distribution |
| 8824-3111 | ACDF PEEK Convex 14x12x11mm | In distribution |
| 8824-4411 | ACDF PEEK 0° 15X20X11MM | In distribution |
| 8830-2708 | PLIF THREADED PEEK 0° 10X27X8MM | In distribution |
| 8824-4712 | ACDF PEEK 5° 14x18x12mm | In distribution |
| 8804-1216 | VBR PEEK 0° 12X14X16MM | In distribution |
| 8804-1238 | VBR PEEK 0° 12x14x38mm | In distribution |
| 8830-2712 | PLIF THREADED PEEK 0° 10X27X12MM | In distribution |
| 8824-4608 | ACDF PEEK 5° 13x16x8mm | In distribution |
| 8824-4107 | ACDF PEEK 0° 12x14x7mm | In distribution |
| 8825-0743 | VBR PEEK 7°/0° 14x18x43mm | In distribution |
| 8824-4705 | ACDF PEEK 5° 14X18X5MM | In distribution |
| 8833-2010 | PLIF THREADED PEEK 6° 10X20X10MM | In distribution |
| 8804-1224 | VBR PEEK 0° 12x14x24mm | In distribution |
| 8880-0116 | ALIF PEEK 0° 24x32x16mm | In distribution |
| 8824-4809 | ACDF PEEK 5° 15X20X9MM | In distribution |
| 8841-2310 | OLIF PEEK 10X23X10MM | In distribution |
| 8804-1234 | VBR PEEK 0° 12x14x34mm | In distribution |
| 8804-1242 | VBR PEEK 0° 12x14x42mm | In distribution |
| 8880-0212 | ALIF PEEK 0° 27x36x12mm | In distribution |
| 8824-4210 | ACDF PEEK 0° 13X16X10MM | In distribution |
| 8858-2508 | TLIF THREADED PEEK 0° 9X25X8MM | In distribution |
| 8880-0114 | ALIF PEEK 0° 24X32X14MM | In distribution |
| 8833-2712 | PLIF THREADED PEEK 6° 10X27X12MM | In distribution |
| 8824-4109 | ACDF PEEK 0° 12X14X9MM | In distribution |
| 8858-3013 | TLIF THREADED PEEK 0° 9X30X13MM | In distribution |
| 8824-3108 | ACDF PEEK Convex 14x12x8mm | In distribution |
| 8804-1234 | VBR PEEK 0° 12X14X34MM | In distribution |
| 8804-1218 | VBR PEEK 0° 12x14x18mm | In distribution |
| 8824-4612 | ACDF PEEK 5° 13x16x12mm | In distribution |
| 8824-4405 | ACDF PEEK 0° 15X20X5MM | In distribution |
| 8824-4709 | ACDF PEEK 5° 14X18X9MM | In distribution |
| 8858-2513 | TLIF THREADED PEEK 0° 9X25X13MM | In distribution |
| 8880-0212 | ALIF PEEK 0° 27X36X12MM | In distribution |
| 8833-2713 | PLIF THREADED PEEK 6° 10X27X13MM | In distribution |
| 8825-0714 | VBR PEEK 7°/0° 14X18X14MM | In distribution |
| 8880-6214 | ALIF PEEK 15° 27x36x14mm | In distribution |
| 8880-6112 | ALIF PEEK 15° 24X32X12MM | In distribution |
| 8880-5120 | ALIF PEEK 12° 24x32x20mm | In distribution |
| 8824-4405 | ACDF PEEK 0° 15x20x5mm | In distribution |
| 8880-3120 | ALIF PEEK 7° 24x32x20mm | In distribution |
| 8833-2012 | PLIF THREADED PEEK 6° 10X20X12MM | In distribution |
| 8824-4208 | ACDF PEEK 0° 13x16x8mm | In distribution |
| 8880-6220 | ALIF PEEK 15° 27x36x20mm | In distribution |
| 8824-4210 | ACDF PEEK 0° 13x16x10mm | In distribution |
| 8825-0735 | VBR PEEK 7°/0° 14X18X35MM | In distribution |
| 8880-0108 | ALIF PEEK 0° 24X32X8MM | In distribution |
| 8880-6116 | ALIF PEEK 15° 24x32x16mm | In distribution |
| 8824-4410 | ACDF PEEK 0° 15x20x10mm | In distribution |
| 8825-0713 | VBR PEEK 7°/0° 14x18x13mm | In distribution |
| 8824-4708 | ACDF PEEK 5° 14x18x8mm | In distribution |
| 8825-0741 | VBR PEEK 7°/0° 14X18X41MM | In distribution |
| 8824-4608 | ACDF PEEK 5° 13X16X8MM | In distribution |
| 8880-5112 | ALIF PEEK 12° 24x32x12mm | In distribution |
| 8825-0729 | VBR PEEK 7°/0° 14X18X29MM | In distribution |
| 8824-4412 | ACDF PEEK 0° 15X20X12MM | In distribution |
| 8880-6120 | ALIF PEEK 15° 24x32x20mm | In distribution |
| 8824-4609 | ACDF PEEK 5° 13X16X9MM | In distribution |
| 8841-3210 | OLIF PEEK 13X32X10MM | In distribution |
| 8841-3209 | OLIF PEEK 13X32X9MM | In distribution |
| 8880-3214 | ALIF PEEK 7° 27x36x14mm | In distribution |
| 8824-3109 | ACDF PEEK Convex 14x12x9mm | In distribution |
| 8824-4305 | ACDF PEEK 0° 14X18X5MM | In distribution |
| 8859-3008 | TLIF CHANNELED PEEK 0° 9X30X8MM | In distribution |
| 8824-4107 | ACDF PEEK 0° 12X14X7MM | In distribution |
| 8858-3012 | TLIF THREADED PEEK 0° 9X30X12MM | In distribution |
| 8880-3110 | ALIF PEEK 7° 24x32x10mm | In distribution |
| 8880-3216 | ALIF PEEK 7° 27X36X16MM | In distribution |
| 8825-0728 | VBR PEEK 7°/0° 14x18x28mm | In distribution |
| 8804-1209 | ACF PEEK 0° 12X14X9MM | In distribution |
| 8825-0743 | VBR PEEK 7°/0° 14X18X43MM | In distribution |
| 8824-4607 | ACDF PEEK 5° 13x16x7mm | In distribution |
| 8880-3120 | ALIF PEEK 7° 24X32X20MM | In distribution |
| 8880-5120 | ALIF PEEK 12° 24X32X20MM | In distribution |
| 8824-4610 | ACDF PEEK 5° 13X16X10MM | In distribution |
| 8824-4508 | ACDF PEEK 5° 12x14x8mm | In distribution |
| 8841-2314 | OLIF PEEK 10X23X14MM | In distribution |
| 8824-4306 | ACDF PEEK 0° 14x18x6mm | In distribution |
| 8824-4707 | ACDF PEEK 5° 14x18x7mm | In distribution |
| 8824-4206 | ACDF PEEK 0° 13X16X6MM | In distribution |
| 8824-4510 | ACDF PEEK 5° 12x14x10mm | In distribution |
| 8824-4710 | ACDF PEEK 5° 14X18X10MM | In distribution |
| 8830-2307 | PLIF THREADED PEEK 0° 10X23X7MM | In distribution |
| 8880-0110 | ALIF PEEK 0° 24X32X10MM | In distribution |
| 8841-2308 | OLIF PEEK 10X23X8MM | In distribution |
| 8880-5218 | ALIF PEEK 12° 27x36x18mm | In distribution |
| 8841-3207 | OLIF PEEK 13X32X7MM | In distribution |
| 8824-4509 | ACDF PEEK 5° 12x14x9mm | In distribution |
| 8814-1218 | VBR PEEK 5° 12X14X18MM | In distribution |
| 8804-1236 | VBR PEEK 0° 12x14x36mm | In distribution |
| 8825-0708 | ACF PEEK 7°/0° 14x18x08mm | In distribution |
| 8880-0208 | ALIF PEEK 0° 27x36x8mm | In distribution |
| 8841-2807 | OLIF PEEK 11X28X7MM | In distribution |
| 8880-5220 | ALIF PEEK 12° 27X36X20MM | In distribution |
| 8858-2510 | TLIF THREADED PEEK 0° 9X25X10MM | In distribution |
| 8804-1240 | VBR PEEK 0° 12X14X40MM | In distribution |
| 8841-2812 | OLIF PEEK 11X28X12MM | In distribution |
| 8830-2312 | PLIF THREADED PEEK 0° 10X23X12MM | In distribution |
| 8804-1215 | VBR PEEK 0° 12X14X15MM | In distribution |
| 8880-0220 | ALIF PEEK 0° 27X36X20MM | In distribution |
| 8825-0731 | VBR PEEK 7°/0° 14x18x31mm | In distribution |
| 8824-4511 | ACDF PEEK 5° 12x14x11mm | In distribution |
| 8880-3118 | ALIF PEEK 7° 24x32x18mm | In distribution |
| 8880-3220 | ALIF PEEK 7° 27x36x20mm | In distribution |
| 8880-3108 | ALIF PEEK 7° 24x32x8mm | In distribution |
| 8824-3107 | ACDF PEEK CONVEX 14X12X7MM | In distribution |
| 8830-2311 | PLIF THREADED PEEK 0° 10X23X11MM | In distribution |
| 8825-0716 | VBR PEEK 7°/0° 14X18X16MM | In distribution |
| 8880-3220 | ALIF PEEK 7° 27X36X20MM | In distribution |
| 8824-4806 | ACDF PEEK 5° 15X20X6MM | In distribution |
| 8814-1206 | ACF PEEK 5° 12X14X6MM | In distribution |
| 8814-1216 | VBR PEEK 5° 12x14x16mm | In distribution |
| 8825-0739 | VBR PEEK 7°/0° 14X18X39MM | In distribution |
| 8824-4105 | ACDF PEEK 0° 12X14X5MM | In distribution |
| 8824-4605 | ACDF PEEK 5° 13x16x5mm | In distribution |
| 8824-4705 | ACDF PEEK 5° 14x18x5mm | In distribution |
| 8824-3109 | ACDF PEEK CONVEX 14X12X9MM | In distribution |
| 8824-4407 | ACDF PEEK 0° 15x20x7mm | In distribution |
| 8824-4812 | ACDF PEEK 5° 15x20x12mm | In distribution |
| 8825-0715 | VBR PEEK 7°/0° 14x18x15mm | In distribution |
| 8841-2313 | OLIF PEEK 10X23X13MM | In distribution |
| 8880-6218 | ALIF PEEK 15° 27X36X18MM | In distribution |
| 8880-6214 | ALIF PEEK 15° 27X36X14MM | In distribution |
| 8824-4308 | ACDF PEEK 0° 14X18X8MM | In distribution |
| 8804-1208 | ACF PEEK 0° 12X14X8MM | In distribution |
| 8880-5218 | ALIF PEEK 12° 27X36X18MM | In distribution |
| 8880-3216 | ALIF PEEK 7° 27x36x16mm | In distribution |
| 8880-6114 | ALIF PEEK 15° 24x32x14mm | In distribution |
| 8825-0726 | VBR PEEK 7°/0° 14x18x26mm | In distribution |
| 8833-2714 | PLIF THREADED PEEK 6° 10X27X14MM | In distribution |
| 8824-4611 | ACDF PEEK 5° 13X16X11MM | In distribution |
| 8824-4410 | ACDF PEEK 0° 15X20X10MM | In distribution |
| 8880-6216 | ALIF PEEK 15° 27x36x16mm | In distribution |
| 8824-4805 | ACDF PEEK 5° 15x20x5mm | In distribution |
| 8858-3010 | TLIF THREADED PEEK 0° 9X30X10MM | In distribution |
| 8880-3118 | ALIF PEEK 7° 24X32X18MM | In distribution |
| 8824-4611 | ACDF PEEK 5° 13x16x11mm | In distribution |
| 8804-1248 | VBR PEEK 0° 12X14X48MM | In distribution |
| 8824-3106 | ACDF PEEK CONVEX 14X12X6MM | In distribution |
| 8824-4511 | ACDF PEEK 5° 12X14X11MM | In distribution |
| 8825-0721 | VBR PEEK 7°/0° 14X18X21MM | In distribution |
| 8824-4209 | ACDF PEEK 0° 13x16x9mm | In distribution |
| 8880-0210 | ALIF PEEK 0° 27X36X10MM | In distribution |
| 8825-0738 | VBR PEEK 7°/0° 14X18X38MM | In distribution |
| 8825-0745 | VBR PEEK 7°/0° 14x18x45mm | In distribution |
| 8825-0707 | ACF PEEK 7°/0° 14x18x07mm | In distribution |
| 8804-1250 | VBR PEEK 0° 12x14x50mm | In distribution |
| 8804-1228 | VBR PEEK 0° 12X14X28MM | In distribution |
| 8824-4108 | ACDF PEEK 0° 12x14x8mm | In distribution |
| 8825-0745 | VBR PEEK 7°/0° 14X18X45MM | In distribution |
| 8804-1218 | VBR PEEK 0° 12X14X18MM | In distribution |
| 8830-2713 | PLIF THREADED PEEK 0° 10X27X13MM | In distribution |
| 8824-4412 | ACDF PEEK 0° 15x20x12mm | In distribution |
| 8858-2512 | TLIF THREADED PEEK 0° 9X25X12MM | In distribution |
| 8824-4409 | ACDF PEEK 0° 15x20x9mm | In distribution |
| 8880-3212 | ALIF PEEK 7° 27X36X12MM | In distribution |
| 8804-1225 | VBR PEEK 0° 12x14x25mm | In distribution |
| 8825-0720 | VBR PEEK 7°/0° 14X18X20MM | In distribution |
| 8841-2309 | OLIF PEEK 10X23X9MM | In distribution |
| 8825-0706 | ACF PEEK 7°/0° 14X18X06MM | In distribution |
| 8825-0748 | VBR PEEK 7°/0° 14X18X48MM | In distribution |
| 8830-2309 | PLIF THREADED PEEK 0° 10X23X9MM | In distribution |
| 8804-1250 | VBR PEEK 0° 12X14X50MM | In distribution |
| 8824-4205 | ACDF PEEK 0° 13X16X5MM | In distribution |
| 8804-1230 | VBR PEEK 0° 12x14x30mm | In distribution |
| 8833-2313 | PLIF THREADED PEEK 6° 10X23X13MM | In distribution |
| 8880-6118 | ALIF PEEK 15° 24x32x18mm | In distribution |
| 8804-1216 | VBR PEEK 0° 12x14x16mm | In distribution |
| 8841-3214 | OLIF PEEK 13X32X14MM | In distribution |
| 8824-4105 | ACDF PEEK 0° 12x14x5mm | In distribution |
| 8825-0709 | ACF PEEK 7°/0° 14X18X09MM | In distribution |
| 8824-4706 | ACDF PEEK 5° 14X18X6MM | In distribution |
| 8824-4110 | ACDF PEEK 0° 12x14x10mm | In distribution |
| 8825-0717 | VBR PEEK 7°/0° 14x18x17mm | In distribution |
| 8830-2714 | PLIF THREADED PEEK 0° 10X27X14MM | In distribution |
| 8804-1235 | VBR PEEK 0° 12x14x35mm | In distribution |
| 8824-4507 | ACDF PEEK 5° 12x14x7mm | In distribution |
| 8804-1225 | VBR PEEK 0° 12X14X25MM | In distribution |
| 8858-3014 | TLIF THREADED PEEK 0° 9X30X14MM | In distribution |
| 8880-5110 | ALIF PEEK 12° 24X32X10MM | In distribution |
| 8824-4610 | ACDF PEEK 5° 13x16x10mm | In distribution |
| 8814-1216 | VBR PEEK 5° 12X14X16MM | In distribution |
| 8880-0114 | ALIF PEEK 0° 24x32x14mm | In distribution |
| 8829-2307 | PLIF CHANNELED PEEK 0° 10X23X7MM | In distribution |
| 8824-4808 | ACDF PEEK 5° 15x20x8mm | In distribution |
| 8825-0719 | VBR PEEK 7°/0° 14x18x19mm | In distribution |
| 8824-4505 | ACDF PEEK 5° 12x14x5mm | In distribution |
| 8824-4310 | ACDF PEEK 0° 14X18X10MM | In distribution |
| 8824-4708 | ACDF PEEK 5° 14X18X8MM | In distribution |
| 8880-0210 | ALIF PEEK 0° 27x36x10mm | In distribution |
| 8804-1248 | VBR PEEK 0° 12x14x48mm | In distribution |
| 8880-5110 | ALIF PEEK 12° 24x32x10mm | In distribution |
| 8880-0110 | ALIF PEEK 0° 24x32x10mm | In distribution |
| 8824-4211 | ACDF PEEK 0° 13x16x11mm | In distribution |
| 8804-1246 | VBR PEEK 0° 12X14X46MM | In distribution |
| 8824-4206 | ACDF PEEK 0° 13x16x6mm | In distribution |
| 8825-0726 | VBR PEEK 7°/0° 14X18X26MM | In distribution |
| 8880-0112 | ALIF PEEK 0° 24X32X12MM | In distribution |
| 8880-0208 | ALIF PEEK 0° 27X36X8MM | In distribution |
| 8833-2708 | PLIF THREADED PEEK 6° 10X27X8MM | In distribution |
| 8880-5212 | ALIF PEEK 12° 27X36X12MM | In distribution |
| 8824-3112 | ACDF PEEK CONVEX 14X12X12MM | In distribution |
| 8841-2810 | OLIF PEEK 11X28X10MM | In distribution |
| 8825-0711 | ACF PEEK 7°/0° 14x18x11mm | In distribution |
| 8824-4209 | ACDF PEEK 0° 13X16X9MM | In distribution |
| 8804-1215 | VBR PEEK 0° 12x14x15mm | In distribution |
| 8824-4606 | ACDF PEEK 5° 13x16x6mm | In distribution |
| 8841-2814 | OLIF PEEK 11X28X14MM | In distribution |
| 8804-1205 | ACF PEEK 0° 12X14X5MM | In distribution |
| 8829-2707 | PLIF CHANNELED PEEK 0° 10X27X7MM | In distribution |
| 8824-3107 | ACDF PEEK Convex 14x12x7mm | In distribution |
| 8824-4411 | ACDF PEEK 0° 15x20x11mm | In distribution |
| 8880-5216 | ALIF PEEK 12° 27x36x16mm | In distribution |
| 8825-0717 | VBR PEEK 7°/0° 14X18X17MM | In distribution |
| 8880-0214 | ALIF PEEK 0° 27X36X14MM | In distribution |
| 8880-6212 | ALIF PEEK 15° 27X36X12MM | In distribution |
| 8880-3214 | ALIF PEEK 7° 27X36X14MM | In distribution |
| 8804-1232 | VBR PEEK 0° 12X14X32MM | In distribution |
| 8825-0720 | VBR PEEK 7°/0° 14x18x20mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063393 | 2007-06-25 |
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.