PxHA®
HA PEEK, Tantalum
14manufacturers in China registered for this device type
113catalogue 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 | Inno-Health Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| Record published | 2017-04-17 |
| Record revised | 2026-01-05 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 8 to 12 mm; height 8 to 16 mm; length 22 to 32 mm; angle 0 to 5 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HA1016225 | Width 10 mm | In distribution |
| HA1210300 | Width 12 mm | In distribution |
| HA1210280 | Width 12 mm | In distribution |
| HA1009225 | Width 10 mm | In distribution |
| HA1009220 | Width 10 mm | In distribution |
| HA0812250 | Width 8 mm | In distribution |
| HA1008250 | Width 10 mm | In distribution |
| HA1016255 | Width 10 mm | In distribution |
| HA0811225 | Width 8 mm | In distribution |
| HA1008320 | Width 10 mm | In distribution |
| HA0813220 | Width 8 mm | In distribution |
| HA1015255 | Width 10 mm | In distribution |
| HA1013280 | Width 10 mm | In distribution |
| HA1010255 | Width 10 mm | In distribution |
| HA0812220 | Width 8 mm | In distribution |
| HA1011250 | Width 10 mm | In distribution |
| HA0815255 | Width 8 mm | In distribution |
| HA1010320 | Width 10 mm | In distribution |
| HA1214280 | Width 12 mm | In distribution |
| HA1210320 | Width 12 mm | In distribution |
| HA1215320 | Width 12 mm | In distribution |
| HA1212280 | Width 12 mm | In distribution |
| HA0808250 | Width 8 mm | In distribution |
| HA1213300 | Width 12 mm | In distribution |
| HA1015250 | Width 10 mm | In distribution |
| HA1010280 | Width 10 mm | In distribution |
| HA0810250 | Width 8 mm | In distribution |
| HA1014225 | Width 10 mm | In distribution |
| HA1013320 | Width 10 mm | In distribution |
| HA1012255 | Width 10 mm | In distribution |
| HA1008280 | Width 10 mm | In distribution |
| HA1209280 | Width 12 mm | In distribution |
| HA0808225 | Width 8 mm | In distribution |
| HA0816220 | Width 8 mm | In distribution |
| HA0812225 | Width 8 mm | In distribution |
| HA0815225 | Width 8 mm | In distribution |
| HA1212320 | Width 12 mm | In distribution |
| HA1014250 | Width 10 mm | In distribution |
| HA0816250 | Width 8 mm | In distribution |
| HA1013255 | Width 10 mm | In distribution |
| HA1012250 | Width 10 mm | In distribution |
| HA0814225 | Width 8 mm | In distribution |
| HA1011220 | Width 10 mm | In distribution |
| HA1211300 | Width 12 mm | In distribution |
| HA0811255 | Width 8 mm | In distribution |
| HA1008225 | Width 10 mm | In distribution |
| HA0813255 | Width 8 mm | In distribution |
| HA1014220 | Width 10 mm | In distribution |
| HA0812255 | Width 8 mm | In distribution |
| HA0811250 | Width 8 mm | In distribution |
| HA1213320 | Width 12 mm | In distribution |
| HA1010220 | Width 10 mm | In distribution |
| HA0809225 | Width 8 mm | In distribution |
| HA1012220 | Width 10 mm | In distribution |
| HA1012280 | Width 10 mm | In distribution |
| HA1216280 | Width 12 mm | In distribution |
| HA1011255 | Width 10 mm | In distribution |
| HA1015220 | Width 10 mm | In distribution |
| HA1009280 | Width 10 mm | In distribution |
| HA0809220 | Width 8 mm | In distribution |
| HA1011280 | Width 10 mm | In distribution |
| HA1213280 | Width 12 mm | In distribution |
| HA0815250 | Width 8 mm | In distribution |
| HA0814250 | Width 8 mm | In distribution |
| HA1013250 | Width 10 mm | In distribution |
| HA1011320 | Width 10 mm | In distribution |
| HA1015225 | Width 10 mm | In distribution |
| HA1014320 | Width 10 mm | In distribution |
| HA0816225 | Width 8 mm | In distribution |
| HA1215300 | Width 12 mm | In distribution |
| HA1216300 | Width 12 mm | In distribution |
| HA1016220 | Width 10 mm | In distribution |
| HA0814220 | Width 8 mm | In distribution |
| HA1209320 | Width 12 mm | In distribution |
| HA0808220 | Angle 0 ° | In distribution |
| HA1011225 | Width 10 mm | In distribution |
| HA0813250 | Width 8 mm | In distribution |
| HA1015320 | Width 10 mm | In distribution |
| HA1009255 | Width 10 mm | In distribution |
| HA0816255 | Width 8 mm | In distribution |
| HA1008220 | Width 10 mm | In distribution |
| HA1216320 | Width 12 mm | In distribution |
| HA0814255 | Width 8 mm | In distribution |
| HA1215280 | Width 12 mm | In distribution |
| HA1015280 | Width 10 mm | In distribution |
| HA1014255 | Width 10 mm | In distribution |
| HA0810225 | Width 8 mm | In distribution |
| HA1211280 | Width 12 mm | In distribution |
| HA1214300 | Width 12 mm | In distribution |
| HA0810220 | Width 8 mm | In distribution |
| HA0809250 | Width 8 mm | In distribution |
| HA0810255 | Width 8 mm | In distribution |
| HA0813225 | Width 8 mm | In distribution |
| HA1010225 | Width 10 mm | In distribution |
| HA1010250 | Width 10 mm | In distribution |
| HA1009320 | Width 10 mm | In distribution |
| HA1016250 | Width 10 mm | In distribution |
| HA1012225 | Width 10 mm | In distribution |
| HA0808255 | Width 8 mm | In distribution |
| HA1013225 | Width 10 mm | In distribution |
| HA1008255 | Width 10 mm | In distribution |
| HA0809255 | Width 8 mm | In distribution |
| HA0811220 | Width 8 mm | In distribution |
| HA1009250 | Width 10 mm | In distribution |
| HA1209300 | Width 12 mm | In distribution |
| HA1012320 | Width 10 mm | In distribution |
| HA1214320 | Width 12 mm | In distribution |
| HA1014280 | Width 10 mm | In distribution |
| HA1013220 | Width 10 mm | In distribution |
| HA1211320 | Width 12 mm | In distribution |
| HA1208280 | Width 12 mm | In distribution |
| HA1212300 | Width 12 mm | In distribution |
| HA0815220 | Width 8 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.