Breckenridge® Intervertebral Body/VBR Fusion System
178 catalogue numbers from 8880-5214, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Bone Graft, Lumbar. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
178catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Biomet Spine, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2020-07-13 |
| 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 |
|---|---|---|
| 8880-5214 | ALIF PEEK 12° 27x36x14mm | In distribution |
| 8804-1222 | VBR PEEK 0° 12X14X22MM | In distribution |
| 8814-1220 | VBR PEEK 5° 12X14X20MM | In distribution |
| 8841-3213 | OLIF PEEK 13X32X13MM | In distribution |
| 8880-0218 | ALIF PEEK 0° 27X36X18MM | In distribution |
| 8804-1224 | VBR PEEK 0° 12X14X24MM | In distribution |
| 8880-6216 | ALIF PEEK 15° 27X36X16MM | In distribution |
| 8880-5216 | ALIF PEEK 12° 27X36X16MM | In distribution |
| 8825-0737 | VBR PEEK 7°/0° 14x18x37mm | In distribution |
| 8841-2808 | OLIF PEEK 11X28X8MM | In distribution |
| 8841-3208 | OLIF PEEK 13X32X8MM | In distribution |
| 8833-2311 | PLIF THREADED PEEK 6° 10X23X11MM | In distribution |
| 8858-2507 | TLIF THREADED PEEK 0° 9X25X7MM | In distribution |
| 8829-2308 | PLIF CHANNELED PEEK 0° 10X23X8MM | In distribution |
| 8814-1215 | VBR PEEK 5° 12x14x15mm | In distribution |
| 8825-0706 | ACF PEEK 7°/0° 14x18x06mm | In distribution |
| 8880-3114 | ALIF PEEK 7° 24x32x14mm | In distribution |
| 8880-3110 | ALIF PEEK 7° 24X32X10MM | In distribution |
| 8859-3014 | TLIF CHANNELED PEEK 0° 9X30X14MM | In distribution |
| 8859-3012 | TLIF CHANNELED PEEK 0° 9X30X12MM | In distribution |
| 8880-3112 | ALIF PEEK 7° 24x32x12mm | In distribution |
| 8825-0714 | VBR PEEK 7°/0° 14x18x14mm | In distribution |
| 8830-2711 | PLIF THREADED PEEK 0° 10X27X11MM | In distribution |
| 8814-1213 | VBR PEEK 5° 12X14X13MM | In distribution |
| 8880-3114 | ALIF PEEK 7° 24X32X14MM | In distribution |
| 8830-2314 | PLIF THREADED PEEK 0° 10X23X14MM | In distribution |
| 8804-1246 | VBR PEEK 0° 12x14x46mm | In distribution |
| 8804-1244 | VBR PEEK 0° 12x14x44mm | In distribution |
| 8833-2307 | PLIF THREADED PEEK 6° 10X23X7MM | In distribution |
| 8833-2312 | PLIF THREADED PEEK 6° 10X23X12MM | In distribution |
| 8880-5118 | ALIF PEEK 12° 24X32X18MM | In distribution |
| 8829-2314 | PLIF CHANNELED PEEK 0° 10X23X14MM | In distribution |
| 8825-0711 | ACF PEEK 7°/0° 14X18X11MM | In distribution |
| 8804-1220 | VBR PEEK 0° 12X14X20MM | In distribution |
| 8829-2311 | PLIF CHANNELED PEEK 0° 10X23X11MM | In distribution |
| 8804-1213 | VBR PEEK 0° 12X14X13MM | In distribution |
| 8830-2310 | PLIF THREADED PEEK 0° 10X23X10MM | In distribution |
| 8880-5114 | ALIF PEEK 12° 24x32x14mm | In distribution |
| 8858-3007 | TLIF THREADED PEEK 0° 9X30X7MM | In distribution |
| 8880-3116 | ALIF PEEK 7° 24x32x16mm | In distribution |
| 8829-2309 | PLIF CHANNELED PEEK 0° 10X23X9MM | In distribution |
| 8880-3212 | ALIF PEEK 7° 27x36x12mm | In distribution |
| 8814-1214 | VBR PEEK 5° 12x14x14mm | In distribution |
| 8814-1212 | ACF PEEK 5° 12X14X12MM | In distribution |
| 8858-3009 | TLIF THREADED PEEK 0° 9X30X9MM | In distribution |
| 8829-2313 | PLIF CHANNELED PEEK 0° 10X23X13MM | In distribution |
| 8804-1232 | VBR PEEK 0° 12x14x32mm | In distribution |
| 8833-2310 | PLIF THREADED PEEK 6° 10X23X10MM | In distribution |
| 8829-2714 | PLIF CHANNELED PEEK 0° 10X27X14MM | In distribution |
| 8825-0732 | VBR PEEK 7°/0° 14X18X32MM | In distribution |
| 8814-1218 | VBR PEEK 5° 12x14x18mm | In distribution |
| 8833-2709 | PLIF THREADED PEEK 6° 10X27X9MM | In distribution |
| 8880-5214 | ALIF PEEK 12° 27X36X14MM | In distribution |
| 8833-2314 | PLIF THREADED PEEK 6° 10X23X14MM | In distribution |
| 8825-0724 | VBR PEEK 7°/0° 14X18X24MM | In distribution |
| 8825-0712 | ACF PEEK 7°/0° 14x18x12mm | In distribution |
| 8830-2710 | PLIF THREADED PEEK 0° 10X27X10MM | In distribution |
| 8804-1211 | ACF PEEK 0° 12X14X11MM | In distribution |
| 8880-0116 | ALIF PEEK 0° 24X32X16MM | In distribution |
| 8858-3011 | TLIF THREADED PEEK 0° 9X30X11MM | In distribution |
| 8825-0746 | VBR PEEK 7°/0° 14x18x46mm | In distribution |
| 8829-2709 | PLIF CHANNELED PEEK 0° 10X27X9MM | In distribution |
| 8833-2707 | PLIF THREADED PEEK 6° 10X27X7MM | In distribution |
| 8833-2011 | PLIF THREADED PEEK 6° 10X20X11MM | In distribution |
| 8829-2708 | PLIF CHANNELED PEEK 0° 10X27X8MM | In distribution |
| 8859-2510 | TLIF CHANNELED PEEK 0° 9X25X10MM | In distribution |
| 8804-1235 | VBR PEEK 0° 12X14X35MM | In distribution |
| 8825-0738 | VBR PEEK 7°/0° 14x18x38mm | In distribution |
| 8880-0216 | ALIF PEEK 0° 27X36X16MM | In distribution |
| 8829-2310 | PLIF CHANNELED PEEK 0° 10X23X10MM | In distribution |
| 8804-1226 | VBR PEEK 0° 12X14X26MM | In distribution |
| 8825-0731 | VBR PEEK 7°/0° 14X18X31MM | In distribution |
| 8880-0112 | ALIF PEEK 0° 24x32x12mm | In distribution |
| 8833-2710 | PLIF THREADED PEEK 6° 10X27X10MM | In distribution |
| 8880-0108 | ALIF PEEK 0° 24x32x8mm | In distribution |
| 8841-2809 | OLIF PEEK 11X28X9MM | In distribution |
| 8804-1244 | VBR PEEK 0° 12X14X44MM | In distribution |
| 8830-2709 | PLIF THREADED PEEK 0° 10X27X9MM | In distribution |
| 8825-0740 | VBR PEEK 7°/0° 14X18X40MM | In distribution |
| 8833-2711 | PLIF THREADED PEEK 6° 10X27X11MM | In distribution |
| 8859-2514 | TLIF CHANNELED PEEK 0° 9X25X14MM | In distribution |
| 8825-0710 | ACF PEEK 7°/0° 14X18X10MM | In distribution |
| 8880-3210 | ALIF PEEK 7° 27X36X10MM | In distribution |
| 8825-0737 | VBR PEEK 7°/0° 14X18X37MM | In distribution |
| 8804-1213 | VBR PEEK 0° 12x14x13mm | In distribution |
| 8841-2311 | OLIF PEEK 10X23X11MM | In distribution |
| 8880-5116 | ALIF PEEK 12° 24X32X16MM | In distribution |
| 8829-2711 | PLIF CHANNELED PEEK 0° 10X27X11MM | In distribution |
| 8825-0744 | VBR PEEK 7°/0° 14x18x44mm | In distribution |
| 8880-3210 | ALIF PEEK 7° 27x36x10mm | In distribution |
| 8804-1242 | VBR PEEK 0° 12X14X42MM | In distribution |
| 8804-1222 | VBR PEEK 0° 12x14x22mm | In distribution |
| 8830-2308 | PLIF THREADED PEEK 0° 10X23X8MM | In distribution |
| 8830-2313 | PLIF THREADED PEEK 0° 10X23X13MM | In distribution |
| 8814-1209 | ACF PEEK 5° 12X14X9MM | In distribution |
| 8858-2514 | TLIF THREADED PEEK 0° 9X25X14MM | In distribution |
| 8880-0120 | ALIF PEEK 0° 24x32x20mm | In distribution |
| 8833-2014 | PLIF THREADED PEEK 6° 10X20X14MM | In distribution |
| 8880-5114 | ALIF PEEK 12° 24X32X14MM | In distribution |
| 8880-5112 | ALIF PEEK 12° 24X32X12MM | In distribution |
| 8804-1220 | VBR PEEK 0° 12x14x20mm | In distribution |
| 8858-2509 | TLIF THREADED PEEK 0° 9X25X9MM | In distribution |
| 8880-6120 | ALIF PEEK 15° 24X32X20MM | In distribution |
| 8841-3211 | OLIF PEEK 13X32X11MM | In distribution |
| 8825-0734 | VBR PEEK 7°/0° 14X18X34MM | In distribution |
| 8880-3116 | ALIF PEEK 7° 24X32X16MM | In distribution |
| 8833-2007 | PLIF THREADED PEEK 6° 10X20X7MM | In distribution |
| 8804-1230 | VBR PEEK 0° 12X14X30MM | In distribution |
| 8814-1213 | VBR PEEK 5° 12x14x13mm | In distribution |
| 8880-6112 | ALIF PEEK 15° 24x32x12mm | In distribution |
| 8825-0722 | VBR PEEK 7°/0° 14x18x22mm | In distribution |
| 8825-0747 | VBR PEEK 7°/0° 14X18X47MM | In distribution |
| 8858-2511 | TLIF THREADED PEEK 0° 9X25X11MM | In distribution |
| 8880-3112 | ALIF PEEK 7° 24X32X12MM | In distribution |
| 8858-3008 | TLIF THREADED PEEK 0° 9X30X8MM | In distribution |
| 8833-2009 | PLIF THREADED PEEK 6° 10X20X9MM | In distribution |
| 8880-0118 | ALIF PEEK 0° 24x32x18mm | In distribution |
| 8880-5220 | ALIF PEEK 12° 27x36x20mm | In distribution |
| 8825-0736 | VBR PEEK 7°/0° 14x18x36mm | In distribution |
| 8880-0120 | ALIF PEEK 0° 24X32X20MM | In distribution |
| 8833-2309 | PLIF THREADED PEEK 6° 10X23X9MM | In distribution |
| 8841-2312 | OLIF PEEK 10X23X12MM | In distribution |
| 8880-6218 | ALIF PEEK 15° 27x36x18mm | In distribution |
| 8814-1205 | ACF PEEK 5° 12X14X5MM | In distribution |
| 8880-5212 | ALIF PEEK 12° 27x36x12mm | In distribution |
| 8804-1236 | VBR PEEK 0° 12X14X36MM | In distribution |
| 8880-0220 | ALIF PEEK 0° 27x36x20mm | In distribution |
| 8880-0218 | ALIF PEEK 0° 27x36x18mm | In distribution |
| 8880-6212 | ALIF PEEK 15° 27x36x12mm | In distribution |
| 8804-1238 | VBR PEEK 0° 12X14X38MM | In distribution |
| 8833-2008 | PLIF THREADED PEEK 6° 10X20X8MM | In distribution |
| 8859-3010 | TLIF CHANNELED PEEK 0° 9X30X10MM | In distribution |
| 8804-1214 | VBR PEEK 0° 12X14X14MM | In distribution |
| 8880-5118 | ALIF PEEK 12° 24x32x18mm | In distribution |
| 8825-0739 | VBR PEEK 7°/0° 14x18x39mm | In distribution |
| 8825-0725 | VBR PEEK 7°/0° 14X18X25MM | In distribution |
| 8880-6220 | ALIF PEEK 15° 27X36X20MM | In distribution |
| 8880-0214 | ALIF PEEK 0° 27x36x14mm | In distribution |
| 8804-1228 | VBR PEEK 0° 12x14x28mm | In distribution |
| 8833-2308 | PLIF THREADED PEEK 6° 10X23X8MM | In distribution |
| 8829-2713 | PLIF CHANNELED PEEK 0° 10X27X13MM | In distribution |
| 8804-1226 | VBR PEEK 0° 12x14x26mm | In distribution |
| 8814-1214 | VBR PEEK 5° 12X14X14MM | In distribution |
| 8804-1240 | VBR PEEK 0° 12x14x40mm | In distribution |
| 8833-2013 | PLIF THREADED PEEK 6° 10X20X13MM | In distribution |
| 8880-3218 | ALIF PEEK 7° 27X36X18MM | In distribution |
| 8829-2710 | PLIF CHANNELED PEEK 0° 10X27X10MM | In distribution |
| 8825-0746 | VBR PEEK 7°/0° 14X18X46MM | In distribution |
| 8880-5210 | ALIF PEEK 12° 27X36X10MM | In distribution |
| 8841-2811 | OLIF PEEK 11X28X11MM | In distribution |
| 8825-0705 | ACF PEEK 7°/0° 14x18x05mm | In distribution |
| 8825-0734 | VBR PEEK 7°/0° 14x18x34mm | In distribution |
| 8880-0118 | ALIF PEEK 0° 24X32X18MM | In distribution |
| 8841-2813 | OLIF PEEK 11X28X13MM | In distribution |
| 8825-0705 | ACF PEEK 7°/0° 14X18X05MM | In distribution |
| 8825-0719 | VBR PEEK 7°/0° 14X18X19MM | In distribution |
| 8814-1207 | ACF PEEK 5° 12X14X7MM | In distribution |
| 8825-0741 | VBR PEEK 7°/0° 14x18x41mm | In distribution |
| 8841-2307 | OLIF PEEK 10X23X7MM | In distribution |
| 8814-1220 | VBR PEEK 5° 12x14x20mm | In distribution |
| 8859-2508 | TLIF CHANNELED PEEK 0° 9X25X8MM | In distribution |
| 8880-3108 | ALIF PEEK 7° 24X32X8MM | In distribution |
| 8859-2512 | TLIF CHANNELED PEEK 0° 9X25X12MM | In distribution |
| 8804-1214 | VBR PEEK 0° 12x14x14mm | In distribution |
| 8804-1245 | VBR PEEK 0° 12x14x45mm | In distribution |
| 8830-2707 | PLIF THREADED PEEK 0° 10X27X7MM | In distribution |
| 8880-6116 | ALIF PEEK 15° 24X32X16MM | In distribution |
| 8825-0710 | ACF PEEK 7°/0° 14x18x10mm | In distribution |
| 8825-0723 | VBR PEEK 7°/0° 14X18X23MM | In distribution |
| 8825-0732 | VBR PEEK 7°/0° 14x18x32mm | In distribution |
| 8825-0736 | VBR PEEK 7°/0° 14X18X36MM | In distribution |
| 8880-5116 | ALIF PEEK 12° 24x32x16mm | In distribution |
| 8829-2712 | PLIF CHANNELED PEEK 0° 10X27X12MM | In distribution |
| 8829-2312 | PLIF CHANNELED PEEK 0° 10X23X12MM | In distribution |
| 8841-3212 | OLIF PEEK 13X32X12MM | In distribution |
| 8825-0721 | VBR PEEK 7°/0° 14x18x21mm | In distribution |
| 8880-3218 | ALIF PEEK 7° 27x36x18mm | In distribution |
| 8814-1215 | VBR PEEK 5° 12X14X15MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153695 | 2016-01-21 |
| K151483 | 2015-07-31 |
| K142634 | 2015-03-12 |
| K112014 | 2011-10-17 |
| K081636 | 2008-08-07 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.