HORNET™Lumbar Spacer System
PLI,SPACER,HORNET,30X10,0 DEG
14manufacturers in China registered for this device type
77catalogue numbers in this listing
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 | Choice Spine, LP |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K073669 |
| Record published | 2015-10-24 |
| Record revised | 2022-09-01 (version 5) |
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 |
| Sizes | Height 8 to 18 mm; length 20 to 32 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PP30-30090 | Height 9 mm | In distribution |
| PP30-30100 | Length 30 mm | In distribution |
| PP30-28130 | Height 13 mm | In distribution |
| PP30-25184 | Height 18 mm | In distribution |
| PP30-30180 | Length 30 mm | In distribution |
| PP30-25180 | Height 18 mm | In distribution |
| PP30-32090 | Height 9 mm | In distribution |
| PP30-20110 | Height 11 mm | In distribution |
| PP30-30150 | Length 30 mm | In distribution |
| PP30-32140 | Height 14 mm | In distribution |
| PP30-25080 | Height 8 mm | In distribution |
| PP30-32110 | Height 11 mm | In distribution |
| PP30-22130 | Height 13 mm | In distribution |
| PP30-25170 | Length 25 mm | In distribution |
| PP30-20090 | Height 9 mm | In distribution |
| PP30-22100 | Length 22 mm | In distribution |
| PP30-25174 | Length 25 mm | In distribution |
| PP30-32170 | Height 17 mm | In distribution |
| PP30-28110 | Length 28 mm | In distribution |
| PP30-32080 | Length 32 mm | In distribution |
| PP30-20120 | Height 12 mm | In distribution |
| PP30-22150 | Height 15 mm | In distribution |
| PP30-25130 | Length 25 mm | In distribution |
| PP30-22120 | Length 22 mm | In distribution |
| PP30-28100 | Height 10 mm | In distribution |
| PP30-25090 | Height 9 mm | In distribution |
| PP30-20160 | Length 20 mm | In distribution |
| PP30-20170 | Height 17 mm | In distribution |
| PP30-28180 | Length 28 mm | In distribution |
| PP30-28170 | Height 17 mm | In distribution |
| PP30-25140 | Height 14 mm | In distribution |
| PP30-20140 | Length 20 mm | In distribution |
| PP30-22110 | Length 22 mm | In distribution |
| PP30-22180 | Length 22 mm | In distribution |
| PP30-28080 | Height 8 mm | In distribution |
| PP30-25144 | Length 25 mm | In distribution |
| PP30-25114 | Length 25 mm | In distribution |
| PP30-30120 | Height 12 mm | In distribution |
| PP30-22080 | Length 22 mm | In distribution |
| PP30-25134 | Height 13 mm | In distribution |
| PP30-20080 | Length 20 mm | In distribution |
| PP30-25120 | Height 12 mm | In distribution |
| PP30-20130 | Length 20 mm | In distribution |
| PP30-28150 | Height 15 mm | In distribution |
| PP30-25154 | Length 25 mm | In distribution |
| PP30-32150 | Height 15 mm | In distribution |
| PP30-22140 | Length 22 mm | In distribution |
| PP30-22160 | Length 22 mm | In distribution |
| PP30-30110 | Height 11 mm | In distribution |
| PP30-30080 | Height 8 mm | In distribution |
| PP30-28140 | Length 28 mm | In distribution |
| PP30-25084 | Length 25 mm | In distribution |
| PP30-25160 | Height 16 mm | In distribution |
| PP30-20150 | Height 15 mm | In distribution |
| PP30-22090 | Height 9 mm | In distribution |
| PP30-32130 | Length 32 mm | In distribution |
| PP30-30160 | Height 16 mm | In distribution |
| PP30-32160 | Height 16 mm | In distribution |
| PP30-30130 | Length 30 mm | In distribution |
| PP30-32100 | Height 10 mm | In distribution |
| PP30-30140 | Length 30 mm | In distribution |
| PP30-28120 | Height 12 mm | In distribution |
| PP30-20100 | Length 20 mm | In distribution |
| PP30-25150 | Length 25 mm | In distribution |
| PP30-22170 | Length 22 mm | In distribution |
| PP30-25124 | Length 25 mm | In distribution |
| PP30-30170 | Height 17 mm | In distribution |
| PP30-28090 | Length 28 mm | In distribution |
| PP30-20180 | Height 18 mm | In distribution |
| PP30-25104 | Length 25 mm | In distribution |
| PP30-25100 | Height 10 mm | In distribution |
| PP30-32180 | Height 18 mm | In distribution |
| PP30-28160 | Length 28 mm | In distribution |
| PP30-32120 | Length 32 mm | In distribution |
| PP30-25164 | Length 25 mm | In distribution |
| PP30-25094 | Height 9 mm | In distribution |
| PP30-25110 | Height 11 mm | 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
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.